A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors

Last updated: August 7, 2024
Sponsor: iTeos Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Anti-PD-1 monoclonal antibody

EOS301984

Clinical Study ID

NCT06547957
APT-008
2023-503844-14-00
  • Ages > 18
  • All Genders

Study Summary

APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA

  • Provide a signed written informed consent before any study-specific evaluation.

  • Be at least 18 years old on the day of signing informed consent.

  • Have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for, or did not tolerate standard approved treatment.

  • Have at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Have adequate organ and marrow function.

  • Agree to use adequate highly effective method of contraception during the study is mandatory, if Women of Childbearing Potential (WOCBP) or male.

EXCLUSION CRITERIA

  • Have received prior systemic anticancer treatment including investigational agents within 4 weeks before the first dose of study treatment.

  • Have major surgery planned or have had a major surgery within 5 weeks before the first dose of the study treatment.

  • Have received prior radiotherapy within 2 weeks before the first dose of study treatment.

  • Have allergy to study treatment(s) or any of its components.

  • Have a history or current evidence of uncontrolled or significant cardiovascular disease. Unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Anti-PD-1 monoclonal antibody
Phase: 1
Study Start date:
July 07, 2023
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

  • Institut Jules Bordet

    Brussels, 1070
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • GZA Ziekenhuizen campus Sint-Augustinus

    Wilrijk, 2610
    Belgium

    Active - Recruiting

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