Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGEN2034 · 1 trial · 2 indications
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Monotherapy | EXPERIMENTAL | Dose of 3 mg/kg intravenous (IV) every 2 weeks for up to 24 months. |
| Name | Type | Description |
|---|---|---|
| AGEN2034 | DRUG | Anti-programmed cell death protein-1 (PD-1) Monoclonal Antibody |
Inclusion Criteria: 1. Voluntarily agree to participate by giving written informed consent. Participation in pharmacogenomics testing is optional. 2. Be ≥18 years of age. 3. Diagnosis and prior systemic treatment: 1. Phase 1: Have a histologically or cytologically confirmed diagnosis of a metas...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
AGEN2034 is an investigational small molecule being developed for the treatment of advanced cancer, including cervical cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AGEN2034 targets PD-1, a protein involved in immune regulation. By targeting PD-1, the drug is designed to modulate the immune system's response to cancer cells, though the exact mechanism of action is not fully detailed in available information.
AGEN2034 is being developed by Agenus Inc., a biopharmaceutical company. Agenus Inc. is publicly traded under the ticker symbol AGEN on the stock market.
AGEN2034 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied for safety and efficacy in clinical trials.
AGEN2034 has one completed clinical trial, identified as NCT03104699, titled "A Study of AGEN2034 in Advanced Tumors and Cervical Cancer." This Phase 1 trial enrolled 211 participants and was conducted across multiple countries, including the United States, Australia, and several European nations.