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Female Urogenital Diseases and Pregnancy Complications

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Immunoglobulins

3+3 Dose escalation: botensilimab, every 3 weeks, starting at dose level 0.1 milligrams/kilogram (mg/kg) up to 4 mg/kg, administered intravenously (IV) for up to 2 years.

3+3 Dose escalation: botensilimab, every 6 weeks, starting at dose level 1 mg/kg up to 4 mg/kg, administered IV for up to 2 years.

3+3 Dose escalation: balstilimab, every 2 weeks, at dose level 3 mg/kg in combination with botensilimab, every 6 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg, administered IV for up to 2 years. Participants enrolled at sites in the United Kingdom (UK) may have the option for extended treatment. An additional cohort will investigate balstilimab, every 3 weeks, at 450 mg in combination with botensilimab every 6 weeks, at 150 mg, administered IV for up to 2 years.

An Fc-engineered anti-CTLA-4 monoclonal antibody

Botensilimab

A fully human monoclonal anti-PD-1 antibody

Balstilimab

Agenus Inc. Clinical Trial Information

Clinical Trials Nurse Navigation

Michael Gordon, MD

Ruth Hailegiorgis

Marwan G Fakih, MD

Teri Mata

Navid Hafez, MD

Lorraine Martinez

Anthony El-Khoueiry, MD

Cindy Tong

Jonathan Goldman, MD

Irving Ledesma

Kim Margolin, MD

Rebeca Elizondo

Breelyn Wilky, MD

Jennifer Pope

Sarah Goldberg, MD

Marialby Donis Ramos

Jonathan Trent, MD

Susan Gotthardt

Andrea Bullock, MD

Benjamin Schlechter, MD

Gabriela Fazilov

Olivia Hapanowicz

Thomas Marron, MD

Sakina Makwana

Cynthia Chen

Brian Henick, MD

Amin Yaqubie

Olivia Heffernan

Ghassan Khaled Abou-Alfa, MD

Melissa Ngirailemesang, RN

Rachel E Sanborn, MD

Becky Norris

Apostolia Tsimberidou, MD, PhD

Hope Moreno, RN

Mahadevan Daruka, MD

Benjamin Durand

Robin Jones, MD

Medical Director

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.

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.

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

TEAEs will include adverse events of special interest, immune-related adverse events, and adverse drug reactions, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

DLTs will include any Grade 2 or greater drug related toxicity for all dose groups, according to NCI CTCAE version 5.0 and protocol specifications.

MTD based on DLT occurrence at DLT period (28 days after first dose) and all TEAEs seen through 90 days following last study dose.

Confirmed ORR will be in the analysis population.

DCR will include complete response, partial response, and stable disease.

Serum botensilimab concentrations measured throughout the study

Serum botensilimab concentration measured throughout the study

Serum botensilimab ADAs measured throughout the study

Agenus Inc.

Spots Global Cancer Trial Database for colorectal cancer without liver metastases