Study of AGEN1571 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Agenus Inc.
Study ID
NCT05377528
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • AGEN1571 — DRUG
    A fully human monoclonal immunoglobulin-like transcript antagonist antibody administered intravenously.
  • Balstilimab — DRUG
    A fully human monoclonal programmed cell death protein 1 antagonist antibody administered intravenously.
  • Botensilimab — DRUG
    A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.

Study Details

This is an open-label, Phase 1, 2-part trial to determine recommended phase 2 doses (RP2Ds) and evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571 both as a monotherapy and in combination with balstilimab (PD-1 inhibitor) and/or botensilimab (2-agent combination or 3-agent combination) in participants diagnosed with advanced solid tumors. Part 1 will be the dose escalation phase to determine the RP2D of AGEN1571 monotherapy or AGEN1571 in combination with balstilimab and/or botensilimab. Part 2 will be the dose expansion phase for specific disease indications. Participants will receive study treatment for up to 2 years, or until any disease progression, unacceptable toxicity, or participant wishes to withdraw consent for any reason.

Key Dates

Start date
Jul 19, 2022
Status verified
Apr 2025
Primary completion
Dec 23, 2024
Completion
Dec 23, 2024

Study Design

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

Arms

  • Experimental: Dose Escalation: AGEN1571
    Participants will receive AGEN1571 monotherapy.
  • Experimental: Dose Escalation: AGEN1571 + Balstilimab
    Participants will receive AGEN1571 with balstilimab.
  • Experimental: Dose Escalation: AGEN1571 + Botensilimab
    Participants will receive AGEN1571 with botensilimab.
  • Experimental: Dose Escalation: AGEN1571 + Balstilimab + Botensilimab
    Participants will receive AGEN1571 with balstilimab and botensilimab.
  • Experimental: Dose Expansion
    AGEN1571 administered at the RP2D for monotherapy or any combination therapy.

Primary Outcome Measure

Number Of Participants With Dose-limiting Toxicities [ Time Frame: Day 1 through Day 42 ]

Locations (6)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Florida Cancer SpecialistsSarasotaFlorida34232-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Lifespan Cancer InstituteProvidenceRhode Island02903-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CASarah Cannon Research Institute at HealthONE· Denver, COFlorida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MAIcahn School of Medicine at Mount Sinai· New York, NYLifespan Cancer Institute· Providence, RI

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