Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Agenus Inc.
Study ID
NCT04121676
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AGEN2373 — DRUG
    An Anti-CD137 Monoclonal Antibody
  • Botensilimab — DRUG
    Anti-CTLA-4 Monoclonal Antibody

Study Details

This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, PK, and PD profiles of AGEN2373 as a monotherapy and in combination with botensilimab (also known as AGEN1181), and to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.

Key Dates

Start date
Sep 26, 2019
Status verified
Jan 2025
Primary completion
Feb 22, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
91 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 2-Week Monotherapy with AGEN2373
    3+3 Dose escalation of AGEN2373 administered by IV.
  • Experimental: 3-Week Monotherapy with AGEN2373
    3+3 Dose escalation of AGEN2373 administered by IV.
  • Experimental: 4-Week Monotherapy with AGEN2373
    3+3 Dose escalation of AGEN2373 administered by IV.
  • Experimental: Combination Therapy with 3-week AGEN2373 Monotherapy Lead-In Combination with 6-week Botensilimab
    3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.
  • Experimental: Combination Therapy with 3-week AGEN2373 in combination with 6-week Botensilimab
    3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.

Primary Outcome Measure

Occurrence of Dose Limiting Toxicity (DLT) [ Time Frame: First 28 days of treatment Q2W and Q4W and First 21 days Q3W ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of Southern California Norris Comprehensive Cancer Center/ HoagLos AngelesCalifornia90033-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
University of MiamiCoral GablesFlorida33146-
Moffitt Cancer CenterTampaFlorida33612-
Atlantic Health SystemMorristownNew Jersey07960-
Roswell Park Comprehensive Cancer CareBuffaloNew York14203-
Columbia UniversityNew YorkNew York10032-
Providence Cancer InstitutePortlandOregon97213-
UPMCPittsburghPennsylvania15232-
Mary Crowley Cancer Research CenterDallasTexas75230-
NEXT OncologySan AntonioTexas78229-
University of WashingtonSeattleWashington98109-

Find similar trials in Los Angeles, CA

By research site
University of Southern California Norris Comprehensive Cancer Center/ Hoag· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COUniversity of Miami· Coral Gables, FLMoffitt Cancer Center· Tampa, FLAtlantic Health System· Morristown, NJRoswell Park Comprehensive Cancer Care· Buffalo, NY

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