A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Purpose
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously. Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.
Conditions
- Cancer
- Advanced Cancer
- Locally Advanced Carcinoma
- Metastatic Solid Tumor
- Breast Cancer
- Prostate Cancer
- Colorectal Cancer
- Pancreatic Cancer
- Liver Cancer
- Angiosarcoma
- Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed unresectable, locally advanced, or metastatic solid tumors. - Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit - Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor - Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life - Have an ECOG performance status of 0 to 1 - Have adequate organ function - LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan - Highly effective contraception for both male and female patients throughout the study
Exclusion Criteria
- Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor - Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed) - Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor) - Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment - Significant (ie, ≥ Grade 2) ocular disturbances - Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding - Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation - Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis - Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment - Has received prior radiotherapy within 2 weeks prior to starting study treatment - Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response - Clinically significant cardiovascular disease - Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication - Has an active infection requiring concurrent systemic antibiotic therapy - A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment - Is breastfeeding or expecting to conceive or father children within the projected duration of the study
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation Phase |
AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma. |
|
|
Experimental Dose Expansion Phase |
AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type. |
|
Recruiting Locations
USC/Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Florida Cancer Specialist
Sarasota 4172131, Florida 4155751 34232
Sarasota 4172131, Florida 4155751 34232
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Sarah Cannon Research Center
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
NEXT Oncology
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
NEXT Oncology
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
Contact:
Blake Patterson
703-783-4505
Blake Patterson
703-783-4505
More Details
- Status
- Recruiting
- Sponsor
- Angiex, Inc.