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NCT02694822 · ClinicalTrials.gov registry record · Phase 1

AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy

A Phase 1 study, sponsored by Agenus.

Completed
Registry status
Phase 1
Development phase
89
Enrollment target

NCT02694822: Completed Phase 1 study, sponsored by Agenus.

NCT02694822 is a Phase 1 study that has completed, run by Agenus. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02694822, a Phase 1 study, has completed, sponsored by Agenus.

COMPLETED
Registry status
Phase 1
Development phase
89 participants
Enrollment target

Study Summary

This is an open-label, Phase 1/2, multicenter study to evaluate the safety, pharmacokinetics, and pharmacodynamics of an anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) human monoclonal antibody (zalifrelimab) in participants with advanced or refractory cancer and in participants who have progressed during treatment with a programmed cell death protein-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor as their most recent therapy. The phase 1 portion of the study has been completed; it enrolled adult participants with refractory, advanced cancer in a 3+3 dose escalation cohort. The phase 2 portion consisted of 51 participants who progressed during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).

Primary Outcome

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.

Interventions

  • DRUG Zalifrelimab

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2016-04
Est. Completion 2022-03-31
Phase Phase 1
Agenus

24 total trials

What the finished NCT02694822 record still lists

NCT02694822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).

The record links to 0 conditions, and to 1 intervention - of which Zalifrelimab is the first listed.

NCT02694822 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02694822 about?

NCT02694822 is a clinical study titled "AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy". This is an open-label, Phase 1/2, multicenter study to evaluate the safety, pharmacokinetics, and pharmacodynamics of an anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) human monoclonal antibody (zalifrelimab) in participants with advanced or refractory cancer and in participants who have ...

What is the current status of trial NCT02694822?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2016-04. Estimated completion is 2022-03-31.

What interventions are being tested in trial NCT02694822?

The interventions under investigation include: Zalifrelimab (DRUG).

Who is sponsoring clinical trial NCT02694822?

This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02694822's enrollment target sits among peer trials

89 649th of 2000 higher than 1,351 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02694822, the US trial registry maintained by the National Library of Medicine. NCT02694822 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.