Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
42

Summary

Conditions
Advanced Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Dose escalationMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This Phase 1 study will enroll up to approximately 86 evaluable adult subjects with refractory cancer (solid tumors) regardless of diagnosis. Subjects may be enrolled into the following cohorts: The trial will consist of a 3+3 dose escalation that will evaluate different combination dose levels of A...

This Phase 1 study will enroll up to approximately 86 evaluable adult subjects with refractory cancer (solid tumors) regardless of diagnosis. Subjects may be enrolled into the following cohorts: The trial will consist of a 3+3 dose escalation that will evaluate different combination dose levels of AGEN2373 monotherapy and in combination with Balstilimab (AGEN2034). Each subject will stay on the dose level at a schedule assigned at trial entry. Subjects can be replaced for any reason other than a DLT. Subjects will receive treatment for ? 2 years or until PD, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal of trial occurs.

Tracking Information

NCT #
NCT04121676
Collaborators
Not Provided
Investigators
Study Director: Medical Director Agenus Inc.