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Monoclonal Antibodies

EOS-448 for Cancer (TIG-006 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by iTeos Belgium SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part 2 (H&N cancer): Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available
Must not have
Have received a live vaccine within 30 days prior to the first dose
Have known primary CNS cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new drug, EOS-448, to see if it is safe and effective against advanced solid tumors.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation of organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's resources, digestive issues like nausea or diarrhea due to gastrointestinal tract involvement by drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My head and neck cancer cannot be cured with surgery or radiation.
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My cancer is advanced or has spread, and there are no standard treatments left.
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I am fully active or have some restrictions but can still care for myself.
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My lung cancer is at stage III or IV and cannot be cured with surgery or chemoradiotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 30 days.
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I have been diagnosed with a primary brain cancer.
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I have had immunotherapy for my head and neck cancer.
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I have had severe lung inflammation or ongoing immune-related side effects from previous treatments.
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I had radiotherapy less than 2 weeks before starting the study treatment.
Select...
I have serious heart problems that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Change from baseline in absolute cell count in the tumor and in peripheral blood
Frequency of activation/exhaustion markers in the tumor and in peripheral blood

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

iTeos Belgium SALead Sponsor
7 Previous Clinical Trials
708 Total Patients Enrolled
iTeos TherapeuticsIndustry Sponsor
10 Previous Clinical Trials
2,406 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,802 Previous Clinical Trials
8,377,849 Total Patients Enrolled
39 Trials studying Melanoma
19,706 Patients Enrolled for Melanoma

Media Library

EOS-448 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05060432 — Phase 1 & 2
Melanoma Research Study Groups: Part 1F - EOS-448 + dostarlimab + inupadenant HC, Part 1E - inupadenant HCl + dostarlimab, Part 1A - EOS-448 + pembrolizumab, Part 1D - EOS-448 + dostarlimab, Part 2D - EOS-448 + dostarlimab, Part 1C - EOS-448 + inupadenant, Part 1G - EOS-448 + dostarlimab + chemotherapies, Part 2C - EOS-448 + dostarlimab, Part 1B - EOS-448 + inupadenant
Melanoma Clinical Trial 2023: EOS-448 Highlights & Side Effects. Trial Name: NCT05060432 — Phase 1 & 2
EOS-448 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05060432 — Phase 1 & 2
~37 spots leftby Nov 2025
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