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NCT03860272 · ClinicalTrials.gov registry record · Phase 1
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
A Phase 1 study of Prostate Cancer and Non-Small Cell Lung Cancer, sponsored by Agenus.
- Active
- Registry status
- Phase 1
- Development phase
- 499
- Enrollment target
- 18
- Study locations
NCT03860272 is a Phase 1 study of Prostate Cancer and Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Agenus. The registered enrollment target is 499 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (18% lower). The trial reports 18 study locations across 10 states.
The verdict
NCT03860272, a Phase 1 study of Prostate Cancer and Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Agenus.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 499 participants
- Enrollment target
- 18
- Study locations
Study Summary
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Conditions Studied
Interventions
- DRUG Balstilimab
- DRUG Botensilimab
Study Locations (18)
California
- City of Hope Comprehensive Cancer Center - Duarte
- The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate - Los Angeles
- University of Southern California Norris Comprehensive Cancer Center - Los Angeles
- UCLA Santa Monica Hematology Oncology - Los Angeles
- Saint John's Cancer Institute - Santa Monica
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Texas
- MD Anderson Cancer Center - Houston
- The University of Texas Health Science Center at San Antonio - San Antonio
Arizona
- HonorHealth Research Institute - Scottsdale
Colorado
- University of Colorado - Aurora
Connecticut
- Yale Cancer Center - New Haven
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03860272
The ClinicalTrials.gov registry entry for NCT03860272 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 499 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (18% lower). The listed sponsor is Agenus, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Balstilimab is the first listed.
NCT03860272 reports 18 study locations spanning 10 distinct geographic areas - top geographies include California, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03860272 about?
NCT03860272 is a clinical study titled "Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer". This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (b...
What is the current status of trial NCT03860272?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 499 participants. The study started on 2019-03-20. Estimated completion is 2027-12.
What conditions does trial NCT03860272 study?
This clinical trial studies the following conditions: Prostate Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Endometrial Cancer, Advanced Cancer.
What interventions are being tested in trial NCT03860272?
The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT03860272?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03860272 being conducted?
This trial has 18 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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