Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)

Summary

This is a Phase 1/2, open-label study of AGEN1884 in combination with AGEN2034 in subjects with locally advanced, recurrent and/or metastatic 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).

Timeline

Start

2017-12-18

Primary completion

2022-07-15

Completion

2022-07-15

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). PMID 34932394 ↗

paper The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders PMID 34932394 ↗

Publications

• O'Malley DM, Neffa M, Monk BJ, Melkadze T, Huang M, Kryzhanivska A, Bulat I, Meniawy TM, Bagameri A, Wang EW, Doger de Speville Uribe B, Hegg R, Ortuzar Feliu W, Ancukiewicz M, Lugowska I. Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study. J Clin Oncol. 2022 Mar 1;40(7):762-771. doi: 10.1200/JCO.21.02067. Epub 2021 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Balstilimab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Balstilimab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Zalifrelimab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Zalifrelimab	Monoclonal antibody	1 mg/kg	Intravenous

Indications