Purpose

This study is an open-label, Phase 1/2, multicenter study to evaluate the safety, tolerability, PK, and PD profiles of a novel Fc-engineered IgG1 anti-CTLA-4 human monoclonal antibody (AGEN1181) monotherapy and in combination with a human monoclonal IgG4 antibody (AGEN2034), and to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors. This study will also determine the RP2D of AGEN1181 monotherapy and in combination with AGEN2034.

Category

IRB Number
20190051HU
NCT Number
NCT03860272
Sponsor
Agenus Inc. -



Study Contact

Principal Investigator
Daruka Mahadevan

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 1/Phase 2
      Study Type
      Interventional
      Allocation
      Non-Randomized
      Intervention Model
      Single Group Assignment
      Intervention Model Description
      Dose escalation
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Advanced Cancer

      2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      6-Week Monotherapy

      		3+3 Dose escalation of AGEN1181, every 6 weeks, starting at dose level 1 mg/kg up to 4 mg/kg administered by IV.
    2. Drug: AGEN1181

      An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody

      Other names:

      • Anti-CTLA-4

      3. Experimental

      3-Week Monotherapy

      		Experimental: Open Label 3+3 Dose escalation of AGEN1181, every 3 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg administered by IV.
    3. Drug: AGEN1181

      An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody

      Other names:

      • Anti-CTLA-4

      4. Experimental

      6-Week Combination Therapy

      		3+3 Dose escalation of AGEN2034, every 3 weeks, at dose level 3 mg/kg in combination with AGEN1181, every 6 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg administered by IV.
    4. Drug: AGEN1181

      An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody

      Other names:

      • Anti-CTLA-4

    5. Drug: AGEN2034

      A fully human monoclonal Anti-PD-1 Antibody

      Other names:

      • Anti-PD-1

      6.