
Search Clinical Trials
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A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Hea1
Pfizer
Healthy Male Volunteers
For this study, the study medicine has been specially prepared to contain radiolabeled
carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon.
Adding a low dose of radiation to the study medicine does not change how the medicine
works but helps to see how the medicine a1 expand
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study. The purpose of this radiolabeled study is to learn how a certain amount of [14C] PF-07799544 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests. Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 to 32 kg per meter squared. The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-07799544 by mouth. Part two will begin at least 14 days after the dose in part one. In part two, participants will receive one full dose of PF-07799544 by mouth and one small dose of [14C] PF-07799544 by intravenous (IV) infusion. IV infusion will be directly injected into the veins. To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand: How much PF-07799544 is taken up into the bloodstream when taken by mouth compared to the dose given by IV How the body removes it from the blood steam. Participants will take part in the study for about 7 weeks, including evaluation at the start and follow-up period. Type: Interventional Start Date: Jun 2026 |
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A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)
Pfizer
Overweight
Obesity
Overweight and/or Obesity
Overweight or Obesity
Overnutrition
This study is being done to learn about the safety and effects of the study drugs,
PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a
placebo (a dummy drug that has no active ingredient in it). expand
This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it). Type: Interventional Start Date: May 2026 |
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Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
Adia Med of Winter Park LLC
Chronic Kidney Disease
Kidney Disease
Kidney Disease, Chronic
Chronic Kidney Disease (CKD)
CKD
The goal of this clinical trial is to learn whether a new regenerative treatment called
AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with
glutathione, is safe and can help improve kidney function in adults with chronic kidney
disease (CKD). In this condition, th1 expand
The goal of this clinical trial is to learn whether a new regenerative treatment called AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with glutathione, is safe and can help improve kidney function in adults with chronic kidney disease (CKD). In this condition, the kidneys gradually lose their ability to filter blood as well as they should. The main questions it aims to answer are whether AdiaVita plus glutathione improves kidney function better than control treatments, as measured by blood tests for estimated glomerular filtration rate (eGFR) and creatinine levels, and whether the treatment is safe with acceptable side effects. Researchers will compare three groups. One group will receive AdiaVita plus glutathione. A second group will receive glutathione plus a placebo for AdiaVita. The third group will receive placebos for both treatments. A placebo looks like the real treatment but contains no active ingredients. This will help determine if the full treatment works better than the controls. Approximately 100 adults aged 18 to 80 with stage 2 to 4 chronic kidney disease may participate. Participants will be randomly assigned to one of the three treatment groups. They will receive monthly intravenous infusions at the clinic for the first three months and apply a skin spray twice daily at home during that period. The study lasts 12 months total for each participant, with regular visits for blood tests, physical exams, and safety monitoring. Certain participants in the control groups may switch to the active AdiaVita treatment after three months if they meet safety criteria. This is a single-blind study, meaning participants will not know which treatment they receive. Participant safety is closely monitored by the research team and an independent board throughout the study. Type: Interventional Start Date: May 2026 |
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CHAMP Lung Cancer Screening Program
Jill Kolesar
Lung Cancer
Early Lung Cancer Detection
The U.S. Preventive Services Task Force recommends annual lung cancer screening (LCS)
with low-dose CT for adults aged 50-80 with a ≥20 pack-year smoking history who currently
smoke or quit within the past 15 years. Despite insurance coverage, only 17% of eligible
Iowans were screened in 2024. Barr1 expand
The U.S. Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose CT for adults aged 50-80 with a ≥20 pack-year smoking history who currently smoke or quit within the past 15 years. Despite insurance coverage, only 17% of eligible Iowans were screened in 2024. Barriers include the complexity of screening and competing demands in primary care. To address these challenges, investigators propose a two-part intervention: a blood-based screening test to simplify LCS and a community pharmacist-led referral program integrated into routine pharmacy care. Eligible patients will be identified at Greenwood Pharmacy in Waterloo, Iowa. Interested individuals will be consented by a pharmacist and engaged in shared decision-making about LCS. Participants may decline screening, complete the DELFI Diagnostics FirstLook lung cancer screening blood test, or pursue CT screening through their primary care physician. Those choosing the blood test will be referred to Cedar Valley Family Medicine. Patients with a positive result will complete a standard shared decision-making visit with their PCP and, if appropriate, undergo confirmatory CT imaging. Patients with a negative result will enter a screening cohort and be re-screened annually for an additional year. Type: Interventional Start Date: Jun 2026 |
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A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
Janssen Research & Development, LLC
Hematologic Neoplasms
The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable
JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D])
of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety
of JNJ-95804306 and determine the1 expand
The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). Type: Interventional Start Date: May 2026 |
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Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization
University of Colorado, Denver
Colorectal Cancer
The goal of this interventional study is to create and test a comprehensive and low
burden text message program within existing Community Health Centers (CHC) electronic
records system to encourage patients to complete at home colorectal cancer (CRC)
screening and to make sure they get follow-up ca1 expand
The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results are abnormal. First, the investigators will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. This information will be used to design the text messages program. - Clinic patients will participate in focus groups - Clinic staff will participate in interviews Second, the investigators will test a series of different message versions in two batches (experiments): - Clinic patients with orders for an at-home colorectal cancer screening kit will receive the different message versions. - In the first batch, the messages that get the most engagement from patients will be selected to be used in the second experiment. - In the second batch, the investigators will test which messages lead to the most colorectal cancer screening completion. - This will be rolled-out within the clinics existing electronic record system. The study team will not receive any information that will identify individual patients. Lastly, the investigators will check again with clinic staff to learn how the program performed, and what would be needed to continue using the text message program in the long run. -Clinic staff will participate in interviews and surveys. Type: Interventional Start Date: Dec 2026 |
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A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participan1
Genentech, Inc.
Advanced Prostate Cancer
Metastatic Prostate Cancer
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and
preliminary activity of GDC-1261 in participants with advanced or metastatic prostate
cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for
subsequent studies. expand
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies. Type: Interventional Start Date: Apr 2026 |
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A Study of LY4302814 in Healthy Participants
Eli Lilly and Company
Healthy
The main purpose of this study is to assess how well LY4302814 is tolerated and what side
effects may occur in healthy participants. Blood tests will be performed to investigate
how the body processes the study drug and how the study drug affects the body. For each
participant, the study will last1 expand
The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days. Type: Interventional Start Date: May 2026 |
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Psilocybin Administration With 5-HT1a Blockade
Johns Hopkins University
Psychedelic Effects in Healthy Volunteers
The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the
acute subjective effects of psilocybin, as measured through subjective survey measures
and acute electroencephalography (EEG). Further, the investigators will assess the
effects of psilocybin on post-acute sleep a1 expand
The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries. Type: Interventional Start Date: Aug 2026 |
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A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUD1
International AIDS Vaccine Initiative
Sudan Virus Disease
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan
Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health. expand
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health. Type: Interventional Start Date: May 2026 |
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS1
Rapport Therapeutics Inc.
Focal Seizure
Epilepsy
Focal Epilepsy
This is a clinical research study for an investigational drug called RAP-219 in adult
participants with focal seizures. This study is being conducted to determine if RAP-219
is safe and effective in reducing focal seizure frequency. expand
This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency. Type: Interventional Start Date: Jun 2026 |
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A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult P1
Incyte Corporation
Renal Impairment
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when
administered orally to adult participants with severe renal impairment or end stage renal
disease. expand
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease. Type: Interventional Start Date: May 2026 |
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Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participan1
Hoffmann-La Roche
Multiple Myeloma
The purpose of this study is to assess the efficacy and safety of cevostamab in
combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC)
in participants with multiple myeloma (MM) who have received one to three prior lines of
therapy and have been exposed to an anti-C1 expand
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide. Type: Interventional Start Date: Jun 2026 |
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A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated W1
Alnylam Pharmaceuticals
Hypertension
The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety
of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with
zilebesiran. expand
The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran. Type: Interventional Start Date: Apr 2026 |
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A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Renaissance Pharma Ltd.
High-Risk Neuroblastoma
Neuroblastoma is the most common type of solid cancer found outside the brain in young
children. Generally, it affects children younger than 5 years old, with the average age
when it is found being just 2 years. Most patients have 'high-risk' disease, with spread
of the disease to different sites (1 expand
Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years. Most patients have 'high-risk' disease, with spread of the disease to different sites (metastases). This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma. Type: Interventional Start Date: Mar 2026 |
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SPARK-CGM Implementation
Montefiore Medical Center
Diabetes Mellitus
Continuous glucose monitoring (CGM) is a technology that helps individuals with diabetes
track their sugar levels in real-time, leading to more in-range blood sugars, fewer
episodes of dangerously low blood sugar, and improved quality of life. Despite these
benefits, CGM is not widely used in prima1 expand
Continuous glucose monitoring (CGM) is a technology that helps individuals with diabetes track their sugar levels in real-time, leading to more in-range blood sugars, fewer episodes of dangerously low blood sugar, and improved quality of life. Despite these benefits, CGM is not widely used in primary care settings, where most people receive their diabetes care. The investigators aim to make CGM more accessible and equitably prescribed in primary care practices. The study team will support primary care to increase CGM use with a program called SPARK-CGM (Supporting Primary Care Adoption, Resources, and Knowledge for CGM) across a large network of primary care clinics at Montefiore Medical Center. This program will provide primary care providers (PCPs) with education, tools, and support to incorporate CGM into their routine care for people with diabetes. Investigators plan to test SPARK-CGM to evaluate whether it increases CGM prescriptions who are eligible to receive this technology. Type: Interventional Start Date: May 2026 |
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CARRII Native Intervention Optimization Trial
University of Virginia
Fetal Alcohol Spectrum Disorders
Pregnancy
Alcohol-Related Disorders
Drinking, Alcohol
Contraception Behavior
The purpose of this study is to identify the best combination of new intervention
components to use with CARRII, the first automated online intervention for
alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native
women and others who can become pregnant. Our goal is1 expand
The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities. Type: Interventional Start Date: Jun 2026 |
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A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
AstraZeneca
Hepatic Impairment
The purpose of this study is to examine the safety and tolerability of AZD6234 and
AZD9550 in participants with hepatic impairment and participants with normal hepatic
function. expand
The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function. Type: Interventional Start Date: Mar 2026 |
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A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
University of Pennsylvania
Insomnia
Insomnia Disorder
Chronic Insomnia
Chronic Insomnia Disorder
The purpose of this study is to assess the relative effectiveness, safety, and durability
of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC)
(melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used
prescription that may have a bette1 expand
The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin). Type: Interventional Start Date: May 2026 |
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Sitagliptin in Recurrent/Progressive Grade 4 Glioma
Kailin Yang, MD, PhD
Glioma
Glioblastoma
Recurrent Glioma
Recurrent Glioblastoma
Grade 4 Malignant Glioma of Brain (Disorder)
Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1)
find out if it is effective at treating gliomas that have returned or progressed after
treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give
when combined with bevacizumab. expand
Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab. Type: Interventional Start Date: Jun 2026 |
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A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Ty1
Alkermes, Inc.
Narcolepsy Type 1
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy
(sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking
ALKS 2680 tablets compared with placebo tablets. expand
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets. Type: Interventional Start Date: Jun 2026 |
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Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (G1
Genmab
Gastrointestinal Cancers
This Phase 2 study will be conducted in different countries around the world with up to
about 160 participants.
The purpose of this study is to evaluate how well Rina-S works against GI cancers.
The medication in this study is Rina-S monotherapy (by itself; no other cancer
treatments). All partic1 expand
This Phase 2 study will be conducted in different countries around the world with up to about 160 participants. The purpose of this study is to evaluate how well Rina-S works against GI cancers. The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective. The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Type: Interventional Start Date: May 2026 |
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At-home taVNS for Neurorehabilitation in Parkinson's Disease
Medical University of South Carolina
Parkinson's Disease
The goal of this clinical trial is to learn if taVNS works to treat symptoms of
Parkinson's Disease in adults. It will also learn about the feasibility and preliminary
efficacy of taVNS administered at home by the participant.
The main questions it aims to answer are:
1. Is at-home taVNS feasib1 expand
The goal of this clinical trial is to learn if taVNS works to treat symptoms of Parkinson's Disease in adults. It will also learn about the feasibility and preliminary efficacy of taVNS administered at home by the participant. The main questions it aims to answer are: 1. Is at-home taVNS feasible and effective for treating symptoms of Parkinson's Disease? How often are participants completing the stimulation protocol? What are the side effects of stimulation experienced by participants? How do participants rate the experience of taVNS sessions at home? How do participants' scores on assessments and questionnaires change with taVNS treatments? 2. How does taVNS impact connections between neural networks in the brain of patients with Parkinson's Disease at rest? Participants will: - Have a baseline MRI scan to take images of their brain. - Complete a series of assessments and questionnaires to evaluate their Parkinson's Disease motor symptoms, cognitive and neuropsychiatric symptoms, and other non-motor symptoms. - Have an initial taVNS session where their threshold to perceive the stimulation will be measured. This value will be used to stimulate each participant at a specific dose relative to their individual perception of stimulation. - Be trained on how to use the taVNS device and system and have one 1-hour taVNS session where their vitals will be monitored. - Self-administer 1-hour daily taVNS sessions for 8 weeks at-home, complete tolerability questionnaires, and weekly remote check-ins with study staff. - After 4-weeks of at-home taVNS, participants will come in-person to repeat the questionnaires and assessments from the first visit. - Following the 8 weeks of taVNS sessions, participants will repeat the MRI scan, assessments and questionnaires from visit 1. - Participants will complete questionnaires remotely 1 month following their last taVNS sessions. Type: Interventional Start Date: Jun 2026 |
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Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung1
Daiichi Sankyo
SCLC
Extensive-stage Small Cell Lung Cancer
The purpose of this Medical Access Program (also referred to as an Expanded Access
Program in the USA) is to provide access to I-DXd for eligible patients with
extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of
treatment (including at least one platinum-based regimen)1 expand
The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study. Type: Expanded Access |
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A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced o1
Bayer
Advanced/Metastatic Colorectal Adenocarcinoma
Researchers are looking for a better way to treat people who have advanced or metastatic
colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called
KRAS.
Colorectal cancer (CRC) is a common type of cancer that affects the large bowel (colon)
or the rectum (the section1 expand
Researchers are looking for a better way to treat people who have advanced or metastatic colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called KRAS. Colorectal cancer (CRC) is a common type of cancer that affects the large bowel (colon) or the rectum (the section at the end of the bowel). When CRC spreads to other parts of the body, it is called advanced or metastatic CRC. Some people with CRC have the G12D mutation in the KRAS protein. This mutation is linked to a poorer outlook and fewer treatment options. Currently, there are no approved treatments that specifically target this mutation. KRAS is a protein that helps control how cells grow and divide. When it is mutated, it can cause cells to grow uncontrollably, leading to cancer. The study drug, BAY 3771249, is designed to block the activity of KRAS with G12D mutation, which may help slow or stop the growth of cancer cells. BAY 3771249 can be given alone or together with another drug called cetuximab. The main purpose of this study is to learn how safe BAY 3771249 is, how well people tolerate it, how the body processes the drug, and whether it can help shrink or control tumors in people with advanced or metastatic CRC that has the KRAS G12D mutation. The study will also look at how BAY 3771249 works when given alone or with cetuximab, especially in people who have already tried other treatments for their cancer. Researchers will measure, among others: The number and seriousness of health problems (adverse events) after receiving BAY 3771249. The number of participants who experience a dose-limiting side effect (DLT) at each dose level. The number of participants whose tumors shrink or disappear (overall response rate, ORR) as measured by standard criteria. How much of the drug is in the blood over time (AUC) and the highest amount in the blood (Cmax). Some participants will receive BAY 3771249 alone (monotherapy), and others will receive BAY 3771249 with cetuximab (combination therapy). The study will start with lower doses and gradually increase to find the highest safe dose (dosage escalation). After the safe dose is found, more participants may join the study to receive it (dosage expansion). In some parts of the study, participants may be randomly assigned to different groups or doses. The study is open-label, meaning both participants and doctors know which treatment is being given. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, even if they do not think it is related to the study treatment. The study doctors and their team will contact participants to learn about their health until they complete the study. If a participant benefits from the treatment, it might be possible to continue receiving BAY 3771249 after the end of the study. The findings from this study may help develop a new treatment option for people with advanced or metastatic CRC with a KRAS G12D mutation. Type: Interventional Start Date: Apr 2026 |