Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zalifrelimab · 2 trials · 3 indications
The ORR was defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) or complete response (CR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
The number of participants with an occurrence of a DLT during dose escalation during the first 21 days of treatment in Phase 1 are reported. Any DLT immediately led to permanent withdrawal of zalifrelimab and balstilimab.
A DLT was defined as a Grade ≥3 adverse drug reaction (ADR), according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, occurring in the DLT evaluation period (28 days after the initial administration of zalifrelimab). An ADR was defined as all noxious and unintended responses to a medicinal product, related to any dose.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. A treatment-related AE was one in which a causal relationship between the medicinal product and the AE was at least a reasonable possibility and could not be ruled out. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Blood samples were collected at designated timepoints to characterize Cmax of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as micrograms/milliliter (ug/mL).
Blood samples were collected at designated timepoints to characterize AUC0-21d of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as hour times ug/mL (hour\*ug/mL).
| Arm | Type | Description |
|---|---|---|
| Phase 1 - Dose 1: Zalifrelimab + Balstilimab | EXPERIMENTAL | Participants received zalifrelimab (1 mg/kg every 6 weeks \[Q6W\]) in combination with balstilimab (1 mg/kg every 2 weeks \[Q2W\]). |
| Phase 1 - Dose 2: Zalifrelimab + Balstilimab | EXPERIMENTAL | Participants received zalifrelimab (1 mg/kg Q6W) in combination with balstilimab (3 mg/kg Q2W). |
| Phase 2: Zalifrelimab + Balstilimab | EXPERIMENTAL | Participants received the RP2D of zalifrelimab (1 mg/kg Q6W) in combination with balstilimab (3 mg/kg Q2W). |
| Zalifrelimab | EXPERIMENTAL | Participants received zalifrelimab intravenously. |
| Name | Type | Description |
|---|---|---|
| Zalifrelimab | DRUG | Zalifrelimab was administered over 30 minutes and following the infusion of balstilimab. |
| Balstilimab | DRUG | Balstilimab infusion was administered over 30 minutes. |
Inclusion Criteria To be eligible for participation in this trial the participant must: 1. Voluntarily agree to participate by giving written informed consent (participation in pharmacogenomics testing is optional). 2. Be ≥18 years of age. 3. Diagnosis: 1. Phase 1: Male or female having a hist...
Zalifrelimab is an investigational anti-CTLA-4 human monoclonal antibody being studied for the treatment of advanced solid cancers and cervical cancer. It is being developed by Agenus Inc. (AGEN) and is currently in Phase 1 clinical development.
Zalifrelimab targets CTLA-4, a protein on T cells that acts as an immune checkpoint. By blocking CTLA-4, the antibody aims to enhance the immune system's ability to fight cancer cells. It is being studied in patients with advanced solid tumors and cervical cancer.
Zalifrelimab is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AGEN. The drug is currently in Phase 1 clinical trials for advanced solid cancers and cervical cancer.
Zalifrelimab is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and efficacy in patients with advanced solid cancers and cervical cancer.
Zalifrelimab has been studied in two completed Phase 1 trials. NCT02694822 evaluated it in patients with advanced solid cancers refractory to PD-1/PD-L1 therapies. NCT03495882 studied it in combination with balstilimab for metastatic or locally advanced solid tumors, including cervical cancer.
Yes, Zalifrelimab is also known as AGEN1884. In clinical trial NCT02694822, the drug was referred to as AGEN1884, an anti-CTLA-4 human monoclonal antibody. Both names refer to the same investigational drug being developed by Agenus Inc.