EOS-448 for Cancer

(TIG-006 Trial)

Recruiting at 56 trial locations

Overseen By iTeos Belgium SA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: iTeos Belgium SA

Must be taking: Anti-PD(L)1 therapy

Must not be taking: Immunotherapy, Chemotherapy

Disqualifiers: CNS cancer, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

153 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you have not received any anti-cancer therapy within 4 weeks before the first dose, so you may need to stop certain cancer treatments. However, the protocol does not specify about other medications, so it's best to discuss with the trial team.

Research Team

Iteos Clinical Trials

Principal Investigator

iTeos Belgium SA

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EOS-448 in combination with various therapies, including pembrolizumab, inupadenant, dostarlimab, and standard of care chemotherapies, depending on the trial arm

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dostarlimab
• EOS-448
• inupadenant
• Pembrolizumab
• SOC chemotherapies

Trial Overview 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.

Participant Groups

Group I: Part 2D - EOS-448 + dostarlimab Experimental Treatment 2 Interventions

Participants with 1L mHNSCC 1 \< CPS \< 20 will receive EOS-448 and dostarlimab at every cycle

Group II: Part 2C - EOS-448 + dostarlimab Experimental Treatment 2 Interventions

Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle

Group III: Part 1G - EOS-448 + dostarlimab + chemotherapies Experimental Treatment 3 Interventions

Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle

Group IV: Part 1F - EOS-448 + dostarlimab + inupadenant HC Experimental Treatment 3 Interventions

Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis

Group V: Part 1E - inupadenant HCl + dostarlimab Experimental Treatment 2 Interventions

Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis

Group VI: Part 1D - EOS-448 + dostarlimab Experimental Treatment 2 Interventions

Participants will receive EOS-448 and dostarlimab at every cycle

Group VII: Part 1C - EOS-448 + inupadenant Experimental Treatment 2 Interventions

Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis

Group VIII: Part 1B - EOS-448 + inupadenant Experimental Treatment 2 Interventions

Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis

Group IX: Part 1A - EOS-448 + pembrolizumab Experimental Treatment 2 Interventions

Participants will receive EOS-448 and pembrolizumab at every cycle

Who Is Running the Clinical Trial?

iTeos Belgium SA

Lead Sponsor

Trials

9

Recruited

950+

iTeos Therapeutics

Industry Sponsor

Trials

11

Recruited

2,500+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School