OncRef

Clinical Trial: NCT03860272

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Agenus Inc.
Information Provided By:Agenus Inc.
Last Update Posted:2026-03-30

Study Overview

Brief 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.

Official Title

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

Conditions

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

Intervention / Treatment

  • Drug: Botensilimab
  • Drug: Balstilimab

Other Study ID Numbers

  • C-800-01

Start Date (Actual)

2019-03-20

Primary Completion Date (Actual)

2025-01-13

Study Completion Date (Estimated)

2027-12

Enrollment (Actual)

499

Study Type

Interventional

Phase

Phase 1