EOS-448 for Cancer
(TIG-006 Trial)
Recruiting in Palo Alto (17 mi)
+56 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: iTeos Belgium SA
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults with advanced solid tumors, including melanoma, lung cancer, and head & neck cancers. Participants must have progressed on anti-PD-(L)1 therapy (for melanoma), or be eligible for first-line metastatic treatment combining anti-PD(L)1 therapy with chemotherapy. They should not have received recent anticancer therapies or live vaccines, nor should they have uncontrolled diseases or certain genetic aberrations indicating other treatments.Inclusion Criteria
My head and neck cancer cannot be cured with surgery or radiation.
My cancer is advanced or has spread, and there are no standard treatments left.
Part 2 (H&N cancer): PD-L1 status positive
+6 more
Exclusion Criteria
My brain metastases have been treated and stable for over a month.
I have not received a live vaccine in the last 30 days.
I have been diagnosed with a primary brain cancer.
+9 more
Participant Groups
The study tests EOS-448 combined with standard care and/or investigational drugs in patients with advanced tumors. It's an open-label phase I/II trial to assess safety, dosage, how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and its ability to fight tumors.
9Treatment groups
Experimental Treatment
Group I: Part 2D - EOS-448 + dostarlimabExperimental Treatment2 Interventions
Participants with 1L mHNSCC 1 \< CPS \< 20 will receive EOS-448 and dostarlimab at every cycle
Group II: Part 2C - EOS-448 + dostarlimabExperimental Treatment2 Interventions
Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Group III: Part 1G - EOS-448 + dostarlimab + chemotherapiesExperimental Treatment3 Interventions
Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Group IV: Part 1F - EOS-448 + dostarlimab + inupadenant HCExperimental Treatment3 Interventions
Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
Group V: Part 1E - inupadenant HCl + dostarlimabExperimental Treatment2 Interventions
Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
Group VI: Part 1D - EOS-448 + dostarlimabExperimental Treatment2 Interventions
Participants will receive EOS-448 and dostarlimab at every cycle
Group VII: Part 1C - EOS-448 + inupadenantExperimental Treatment2 Interventions
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Group VIII: Part 1B - EOS-448 + inupadenantExperimental Treatment2 Interventions
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Group IX: Part 1A - EOS-448 + pembrolizumabExperimental Treatment2 Interventions
Participants will receive EOS-448 and pembrolizumab at every cycle
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pittsburg Medical CenterPittsburgh, PA
The Gabrail Pharmacology Phase 1 Research Center LLCCanton, OH
University of California San DiegoSan Diego, CA
Innovative Clinical Research Institute, LLCWhittier, CA
More Trial Locations
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Who Is Running the Clinical Trial?
iTeos Belgium SALead Sponsor
iTeos TherapeuticsIndustry Sponsor
GlaxoSmithKlineIndustry Sponsor