Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

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

Advanced Cancer Angiosarcoma Colorectal Cancer Without Liver Metastases Endometrial Cancer Fibrolamellar Carcinoma Non-small-cell Lung Cancer Ovarian Cancer Prostate Cancer

Interventions / Drugs

Botensilimab Balstilimab

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment499 participants

Primary Completion—

Lead SponsorAgenus Inc.

Data Retrieved2026-04-11 02:52:45.212121+00:00

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