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
Open to Enrollment
Yes
Sponsor
Agenus Inc. -



Study Contact

Principal Investigator
Daruka Mahadevan

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Daruka Mahadevan
(210) 450-1226
mahadevand@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
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.
    3. Drug: AGEN1181

      An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody

      Other names:

      • Anti-CTLA-4

    4. 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.
    5. Drug: AGEN1181

      An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody

      Other names:

      • Anti-CTLA-4

    6. 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.
    7. Drug: AGEN1181

      An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody

      Other names:

      • Anti-CTLA-4

    8. Drug: AGEN2034

      A fully human monoclonal Anti-PD-1 Antibody

      Other names:

      • Anti-PD-1