
Search Clinical Trials
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A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
Boehringer Ingelheim
Type 2 Diabetes
This study aims to find out whether a study medicine called survodutide helps people
control their blood sugar. Adults who live with type 2 diabetes and with a body mass
index (BMI) of 23 kg/m2 or higher can join.
The study has 3 parts. In each part the study compares survodutide with placebo.
Sur1 expand
This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to - Part A: healthy eating and physical activity - Part B: diabetes tablets (no injection of insulin) - Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment. Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works. Type: Interventional Start Date: Aug 2026 |
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Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidit1
AbbVie
Obesity
Overweight
Obesity is a condition where a person has excessive body fat, defined by a body mass
index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of
various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in
participants with obesity or overweight wit1 expand
Obesity is a condition where a person has excessive body fat, defined by a body mass index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in participants with obesity or overweight with weight-related comorbidities. ABBV-295 is an investigational long-acting amylin analog being developed for chronic weight management. Participants are placed into multiple treatment groups with different dosing paradigms of ABBV-295 or placebo. Participants will not know which treatment they are receiving, and there is a chance of being assigned to placebo. Adults with obesity or overweight (as defined by BMI) with weight-related comorbidities will be enrolled. Approximately 360 participants will be enrolled in the study at approximately 70 sites in the United States and Puerto Rico. Participants will receive subcutaneous (SC) injections of ABBV-295 solution for injection or matching placebo administered via pre-filled syringes for 52 weeks during the Double-Blind Period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Aug 2026 |
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Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
Tulane University
Maternal Health Care
Hypertensive Disorder of Pregnancy
Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM,
particularly among those with limited access to health care expand
Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care Type: Interventional Start Date: Jul 2026 |
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Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
Aspeya, Inc.
Safety in Asthma Patients
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2
period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a
single inhaled dose of ASY202 in adults with stable asthma.
Following screening, eligible participants will be enrolled and r1 expand
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma. Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods. During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours. Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study. A follow-up visit will occur after the last dose to assess ongoing safety and tolerability. Type: Interventional Start Date: May 2026 |
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Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma
Henry M. Jackson Foundation for the Advancement of Military Medicine
Non-Hodgkin Lymphoma
Lymphoma Non-Hodgkin
B-cell Lymphoma
Immune Dysregulation
The goal of this observational cohort study is to learn how toxin and occupational
exposures, germline genetic variation, and immune dysregulation relate to B-cell
non-Hodgkin lymphoma among active-duty service members and other Military Health System
beneficiaries. The main questions are whether s1 expand
The goal of this observational cohort study is to learn how toxin and occupational exposures, germline genetic variation, and immune dysregulation relate to B-cell non-Hodgkin lymphoma among active-duty service members and other Military Health System beneficiaries. The main questions are whether specific exposures and germline variants are associated with B-cell NHL subtype, immune dysfunction, and clinical outcomes. Participants will complete exposure and medical-history surveys, provide biospecimens for immune and genomic testing, and may be followed annually for up to 3 years. Type: Observational Start Date: May 2025 |
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Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE]1
Aspeya, Inc.
Migraine
This study is testing an investigational inhaled migraine medication to see how well it
works, how safe it is, and how well people tolerate it. Adults with migraine will receive
both the study medication (ASY202) and a placebo (inactive treatment) at different times
during the study. Neither partic1 expand
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur. Following screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2. The study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit. Type: Interventional Start Date: May 2026 |
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Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
PleoPharma, Inc.
Cannabis Withdrawal
This study is a randomized, double-blind, placebo and active-controlled, multicenter
trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated
with discontinuing cannabis in participants with moderate to severe cannabis use disorder
(CUD). Study participants will receiv1 expand
This study is a randomized, double-blind, placebo and active-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe cannabis use disorder (CUD). Study participants will receive PP-01, nabilone, or placebo every day for 34 days. The total study duration will be approximately 78 days, including screening and a one-week inpatient stay. Following the initial inpatient portion of the study, participants will return to the clinic for six clinic visits and complete two telemedicine appointments. Participants will complete daily symptom diaries and other study-related questionnaires. Participants who complete the core study may be eligible to participate in a repeat dosing extension study if they meet required criteria. Type: Interventional Start Date: Jun 2026 |
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Study of EVO756 in Adults With Migraine
Evommune, Inc.
Migraine
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with
migraine. expand
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine. Type: Interventional Start Date: Jul 2026 |
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic1
AbbVie
Diabetic Retinopathy
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood
sugar levels damage the blood vessels in the back part of the eye (called the retina).
Over time, this damage can lead to vision problems and even blindness if not treated.
This study will assess surabgene lomp1 expand
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME). This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico. In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jun 2026 |
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ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
Ionis Pharmaceuticals, Inc.
Dravet Syndrome
The primary purpose of this study is to evaluate the safety and tolerability of ION337 in
participants with Dravet syndrome (DS). expand
The primary purpose of this study is to evaluate the safety and tolerability of ION337 in participants with Dravet syndrome (DS). Type: Interventional Start Date: May 2026 |
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A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Merck Sharp & Dohme LLC
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL)
called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a
slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the
lymphatic system that causes swollen lymph nod1 expand
Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system. In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer. The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment. Type: Interventional Start Date: May 2026 |
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THIO and Cadonilimab in Resectable Hepatocellular Carcinoma
University of Texas Southwestern Medical Center
Resectable Hepatocellular Carcinoma
The goal of this clinical study is to find out if cadonilimab or ateganosine plus
cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC). expand
The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC). Type: Interventional Start Date: Sep 2026 |
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Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
Scholar Rock, Inc.
Facioscapulohumeral Muscular Dystrophy
FSHD
A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a
monotherapy in participant with FSHD expand
A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD Type: Interventional Start Date: Jul 2026 |
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Mammogram Pretreatment With Ulipristal Acetate
OHSU Knight Cancer Institute
Mammography Screening
Breast Density
This phase II trial tests whether taking ulipristal acetate prior to a mammogram
decreases breast density for people with a history of dense breast tissue. One limitation
to breast cancer screening with mammography is dense breast tissue, which decreases the
sensitivity of screening as breast densi1 expand
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of dense breast tissue. One limitation to breast cancer screening with mammography is dense breast tissue, which decreases the sensitivity of screening as breast density masks cancer and precancerous lesions. Ulipristal acetate lowers the amount of progesterone made by the body which may temporarily decrease the density of the breast tissue, allowing for a more accurate mammogram for people with dense breast tissue. Type: Interventional Start Date: Aug 2026 |
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Dissemination of BREASTChoice AIM1-B
UNC Lineberger Comprehensive Cancer Center
Breast Cancer
Breast Neoplasms
This registration covers only Aim 1b, which focuses on testing usability. The study will
include 20 participants who are breast cancer patients. Participants will be observed
using the tool on their mobile devices, and their experience will be evaluated using a
"think-aloud" method to capture their1 expand
This registration covers only Aim 1b, which focuses on testing usability. The study will include 20 participants who are breast cancer patients. Participants will be observed using the tool on their mobile devices, and their experience will be evaluated using a "think-aloud" method to capture their thoughts and reactions. Interviews will include open-ended questions about the content and format of the decision aid, with follow-up prompts to gather feedback on design elements (length, order, graphics), comprehension, ease of use, acceptance, and engagement with the tool. Knowledge will be measured using the Decision Quality Instrument before and after using the tool. Results will be analyzed to develop recommendations for the final version of the tool. Type: Interventional Start Date: Oct 2025 |
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A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokineti1
Amgen
Uncontrolled Gout
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg
subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg
intravenously (IV) every two weeks with MTX on the response rate during Month 6, as
measured by the sustained normalization of serum1 expand
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6. Type: Interventional Start Date: Feb 2026 |
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An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic1
University of Pittsburgh
Pharmacogenetics
Depression - Major Depressive Disorder
Pharmacogenomic Drug Interaction
Community Pharmacy Services
The goal of this prospective, randomized clinical trial is to learn whether
pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists
in community pharmacies will improve antidepressant treatment outcomes.
The primary aim is to determine whether comprehensive medica1 expand
The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes. The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care. Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes. Type: Interventional Start Date: Sep 2026 |
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A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Elevar Therapeutics
FGFR2 Gene Fusion/Rearrangement
Other Solid Tumors, Adult
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe
to treat adult patients with previously treated, unresectable, locally advanced or
metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or
rearrangement.
Participants will:
- Take1 expand
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: - Take lirafugratinib regularly as instructed by their study doctor. - Visit the clinic as instructed for checkups and tests. - Keep a diary recording each time a dose of lirafugratinib is taken. Type: Interventional Start Date: Jun 2026 |
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CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AML
University of Colorado, Denver
Refractory Acute Myeloid Leukemia (AML)
Relapsed Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome
AML (Acute Myeloid Leukemia)
This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion,
persistence, and preliminary clinical activity of lentivirally transduced autologous T
cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and
4-1BB (CD3ζ/4-1BB) costimulatory doma1 expand
This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ/4-1BB) costimulatory domains in subjects with refractory or relapsed (R/R) acute myeloid leukemia (AML). This CAR T cell product will be referred to as "CD64 CAR T" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R/R AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design. Type: Interventional Start Date: Dec 2026 |
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Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for P1
Alliance for Clinical Trials in Oncology
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus
zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic
leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications
called B-cell lymphoma-2 (BCL-2) inhi1 expand
This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL. Type: Interventional Start Date: Apr 2026 |
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A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate1
Hoffmann-La Roche
Metastatic Castration-Resistant Prostate Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus
enzalutamide compared with physician's choice of alternative androgen receptor pathway
inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic
castrate-resistant prostate cancer (mCRPC) w1 expand
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi. Type: Interventional Start Date: Mar 2026 |
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Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine
Johns Hopkins University
Migraine
Chronic Migraine Headache
Refractory Migraine
This study is to test the safety and feasibility of a procedure called embolization of
the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a
plug in the arteries. MMA embolization with Onyx is not approved for use in patients with
migraines, but is currently used1 expand
This study is to test the safety and feasibility of a procedure called embolization of the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a plug in the arteries. MMA embolization with Onyx is not approved for use in patients with migraines, but is currently used in patients with subdural hematomas. The FDA is allowing the use of Onyx in this study. It is thought that by using Onyx to block the middle meningeal arteries, the amount of migraine-causing substances which are released into the brain's bloodstream will be reduced. The company that manufactures Onyx, Medtronic, is providing the supplies for this study. Participants will be in the study for about 8 months after enrolling, including 6 months of follow up after the procedure. The participants will be asked to complete a daily headache diary and continue the participant's regular migraine medications. Participants will also have several clinic visits and be asked to provide blood samples for research. Type: Interventional Start Date: Apr 2026 |
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A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) a1
Merck Sharp & Dohme LLC
Cervical Cancer
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer
is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer
has spread to other parts of the body.
Researchers want to learn about giving the study medicine sacituzumab tirumotec1 expand
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: - About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and - If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment Type: Interventional Start Date: Jan 2026 |
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A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and1
Ipsen
Advanced Solid Tumor
Metastatic Solid Tumor
The purpose of this study is to determine the appropriate dosage, safety and
effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Advanced solid tumours are cancers that can occur in various organs or tissues and have
spread from their original site to nearby tissues or ot1 expand
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body. There will be two parts to this study: - Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. - Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability. An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib. Each part will consist of the following periods: - A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. - A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first. There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier. In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded. Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time. Type: Interventional Start Date: Feb 2026 |
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Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage1
Boehringer Ingelheim
Non-small Cell Lung Cancer
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can
improve outcomes compared with standard adjuvant treatment in adults with completely
resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating
HER2 tyrosine kinase domain (TKD) muta1 expand
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed. Type: Interventional Start Date: Jan 2026 |