Trials / Active Not Recruiting
Active Not RecruitingNCT03860272
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 499 (actual)
- Sponsor
- Agenus Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This Phase 1 study will enroll up to approximately 550 evaluable adult participants with refractory, advanced cancer (solid tumors). The study will consist of a 3+3 dose escalation. Different dose levels of botensilimab, both monotherapy and in combination with balstilimab, will be evaluated in individual cohorts based upon dose. Each participant will remain in the cohort of the dose level and schedule assigned at study entry. Participants can be replaced for any reason other than a dose-limiting toxicity (DLT). Participants will receive treatment for ≤ 2 years or until progressive disease, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal of trial occurs. Additionally, the study is intended to further explore the safety, PK, PD, and clinical activity in selected cancer types at dose levels (botensilimab monotherapy and combination therapy with balstilimab) determined as potentially effective. Indications of interest include, but are not limited to, non-small-cell lung cancer, melanoma, endometrial cancer, ovarian cancer, angiosarcoma, colorectal cancer without liver metastases, prostate cancer, and fibrolamellar carcinoma.
Conditions
- Advanced Cancer
- Angiosarcoma
- Colorectal Cancer Without Liver Metastases
- Endometrial Cancer
- Fibrolamellar Carcinoma
- Non-small-cell Lung Cancer
- Ovarian Cancer
- Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Botensilimab | An Fc-engineered anti-CTLA-4 monoclonal antibody |
| DRUG | Balstilimab | A fully human monoclonal anti-PD-1 antibody |
Timeline
- Start date
- 2019-03-20
- Primary completion
- 2025-01-13
- Completion
- 2027-12-01
- First posted
- 2019-03-01
- Last updated
- 2026-03-30
Locations
18 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03860272. Inclusion in this directory is not an endorsement.