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Clinical Trial Summary

This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in subjects with advanced solid tumors including cervical cancer.

Clinical Trial Description

This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in subjects with advanced solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T lymphocyte antigen-4 (CTLA-4).

The study consists of two phases:

- Phase 1: Dose escalation

- Phase 2: Expansion in Select Tumors - CERVICAL

Phase 1: Part A - Dose Escalation:

The study will consist initially of a 3+3 dose escalation that will evaluate different combination dose levels of AGEN1884 and AGEN2034 in subjects with advanced / refractory solid tumors.

Phase 2: Expansion in Select Tumors

To further characterize safety and efficacy, the following expansion cohort will be enrolled:

Part B - recurrent, unresectable, or metastatic cervical cancer In Phase 2, the selected CDL of AGEN2034 and AGEN1884, established in Part A, will be administered for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drugs or withdrawal from the trial occurs.

For the Phase 2 portion of the study, an Independent Data Management Committee (IDMC) will be established to evaluate safety and efficacy and an Independent Endpoint Review Committee (IERC) will be established to adjudicate tumor response. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03495882
Study type Interventional
Source Agenus Inc.
Contact Sara Coulter
Phone 781.674.4480
Status Recruiting
Phase Phase 1/Phase 2
Start date December 18, 2017
Completion date March 4, 2023

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