Study on EOS-448 with Standard and Experimental Treatments for Advanced Solid Tumors

Sponsor: iTeos Belgium SA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05060432

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, EOS-448, when used with standard treatments and other experimental therapies in adults with advanced solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective EOS-448 is when combined with standard cancer treatments or other experimental drugs in patients with advanced solid tumors. It will also look at how the body processes the drug and its effects on the tumors.

Description

This study is exploring different combinations of the new drug EOS-448 with other treatments to see how well they work together against advanced solid tumors. The combinations being tested include:

  • EOS-448 with pembrolizumab, a drug that helps the immune system fight cancer.
  • EOS-448 with inupadenant, an experimental drug that blocks a specific receptor involved in cancer growth.
  • EOS-448 with dostarlimab, another immune-boosting drug.
  • Inupadenant with dostarlimab.
  • EOS-448 with both inupadenant and dostarlimab.
  • EOS-448 with dostarlimab and standard chemotherapy for non-small cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate in the trial.
  • Must have a measurable tumor as per standard criteria.
  • Must be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ function.
  • For Parts 1A/1B/1C/1D/1E/1F: Must have an advanced or metastatic solid tumor with no standard treatment options available.

For Part 1G (NSCLC):

  • Must have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Must be eligible for first-line treatment with anti-PD(L)1 therapy and chemotherapy.

For Part 2 (Head and Neck Cancer):

  • Must have advanced head and neck cancer that cannot be cured with local treatments.
  • Must have a positive PD-L1 status.

Exclusion Criteria

  • Cannot have received any cancer treatment within 4 weeks before starting the study.
  • Cannot have received a live vaccine within 30 days before starting the study.
  • Cannot have primary cancer in the central nervous system (CNS).
  • Cannot have untreated CNS metastases unless they have been treated and stable for at least 1 month.
  • Cannot have another active cancer unless in complete remission for at least 2 years.
  • Cannot have a history of severe lung inflammation, active autoimmune disease, or ongoing immune-related side effects from previous treatments.
  • Cannot have unresolved side effects from previous cancer treatments unless they are mild or stable.
  • Cannot have uncontrolled heart disease.
  • For Part 1: Cannot have had major surgery within 3 weeks before starting the study.
  • For Part 1: Cannot have had radiation therapy within 2 weeks before starting the study.

For Part 2 (Head and Neck Cancer):

  • Cannot have had previous immunotherapy targeting specific immune pathways.
  • Cannot have had chemotherapy for advanced or recurrent cancer unless it was completed more than 6 months before screening.

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