Phase 1 study of AGEN1181 alone or with AGEN2034 in advanced cancer
Research type
Research Study
Full 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
IRAS ID
1007705
Contact name
Rim Imam
Contact email
Sponsor organisation
Agenus Inc.
Clinicaltrials.gov Identifier
Research summary
This research study aims to test the safety and tolerability of the study drugs AGEN1181 and balstilimab, and to determine the most appropriate dose of AGEN1181 given alone and in combination with balstilimab for future studies. Participants with cancer that is a locally advanced solid tumour or has spread to new areas of the body for which no standard therapy is available or standard therapy has failed will be included in this study.
AGEN1181 targets cells that are a part of the body’s immune system to block a protein called cytotoxic T-lymphocyte associated protein-4 (CTLA-4). Balstilimab can specially block a protein called programmed-death 1 (PD-1), and prevent communication between this protein and receptors on the tumour cells. These receptors are known to affect the body’s defence mechanism to identify and fight against cancerous cells. Blocking these proteins is believed to improve the ability of participants immune system to fight cancer.
At the time of this revision, the dose escalation part of the study has been completed. AGEN1181 at 0.1, 0.3, 1, 2 and 3 mg/kg have been evaluated in the participants. Moving forward, participants will either receive the study drug AGEN1181 alone (monotherapy) or AGEN1181 in combination with balstilimab. This study is “open-label”, which means that participants and their study doctor will know which study drug or which dose they are receiving.
Participants will be closely monitored for safety and study drug related reactions. Study drug will be given for approximately 2 years or as long as a participants’ cancer does not progress whilst on treatment or if participants meet any other study withdrawal criteria.
The Sponsor of the study is Agenus Inc. The study will include approx. 450 participants, from approx. 20 study sites globally.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0445
Date of REC Opinion
20 Jul 2023
REC opinion
Further Information Favourable Opinion