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

Summary

Participation Requirements

Description

This Phase 1/2 study will enroll up to approximately 86 evaluable adult subjects with refractory cancer (solid tumors) regardless of diagnosis. Subjects may be enrolled into the following cohorts: Cohort 1: AGEN1181 every 3 weeks at 0.1, 0.3, 1, 2, and 4 mg/kg Cohort 2: AGEN1181 every 6 weeks at 1, ...

This Phase 1/2 study will enroll up to approximately 86 evaluable adult subjects with refractory cancer (solid tumors) regardless of diagnosis. Subjects may be enrolled into the following cohorts: Cohort 1: AGEN1181 every 3 weeks at 0.1, 0.3, 1, 2, and 4 mg/kg Cohort 2: AGEN1181 every 6 weeks at 1, 2, and 3 mg/kg Cohort 3: AGEN2034 every 2 weeks at 3 mgkg + AGEN1181 every 6 weeks at 0.1, 0.3, 1, 2, and 4 mg/kg. The trial will consist of a 3+3 dose escalation that will evaluate different dose levels of AGEN1181 monotherapy and in combination with AGEN2034. Each subject will stay on the dose level an schedule assigned at trial entry. Subjects can be replaced for any reason other than a DLT. Subjects will receive treatment for ? 2 years or until PD, 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, pharmacodynamics, and clinical activity in selected cancer types at dose levels (AGEN1181 monotherapy and combination therapy with AGEN2034) determined as potentially effective. Indications of interest include, but are not to limited to Non-Small-Cell Lung Cancer (NSCLC) refractory to prior PD-1/PD-L1 inhibitor treatment, melanoma refractory to prior PD-1/PD-L1 inhibitor treatment, hepatocellular carcinoma (HCC), endometrial cancer, and angiosarcoma.

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