Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

Part of paid clinical trials in San Diego, California.

Sponsor
iTeos Belgium SA
Study ID
NCT05060432
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • EOS-448 — DRUG
    Anti-TIGIT monoclonal antibody
  • pembrolizumab — DRUG
    Anti-PD-1 monoclonal antibody
  • inupadenant — DRUG
    A2A receptor antagonist
  • Dostarlimab — DRUG
    Anti-PD-1 monoclonal antibody
  • SOC chemotherapies — DRUG
    SOC chemotherapies in 1L mNSCLC

Study Details

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

Key Dates

Start date
Sep 6, 2021
Status verified
Jun 2024
Primary completion
Jul 31, 2024
Completion
Jul 31, 2025

Study Design

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

Arms

  • Experimental: Part 1A - EOS-448 + pembrolizumab
    Participants will receive EOS-448 and pembrolizumab at every cycle
  • Experimental: Part 1B - EOS-448 + inupadenant
    Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
  • Experimental: Part 1C - EOS-448 + inupadenant
    Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
  • Experimental: Part 1D - EOS-448 + dostarlimab
    Participants will receive EOS-448 and dostarlimab at every cycle
  • Experimental: Part 1E - inupadenant HCl + dostarlimab
    Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
  • Experimental: Part 1F - EOS-448 + dostarlimab + inupadenant HC
    Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
  • Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies
    Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
  • Experimental: Part 2C - EOS-448 + dostarlimab
    Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
  • Experimental: Part 2D - EOS-448 + dostarlimab
    Participants with 1L mHNSCC 1 \< CPS \< 20 will receive EOS-448 and dostarlimab at every cycle

Primary Outcome Measure

Percentage of participants with DLT and Adverse Events [ Time Frame: From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92037-
Hackensack University Medical CenterBergenNew Jersey07601-

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