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Active, Not Recruiting

NCT Number: NCT06547957

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EOS301984

Drug

Multiple doses of EOS301984

Other names: EOS-984

Anti-PD-1 monoclonal antibody

Drug

Multiple doses of EOS301984 in combination with Anti-PD-1

Primary outcomes

  1. To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors

    Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)

  2. Incidence and severity of AEs in patients receiving EEOS301984

    Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)

Secondary outcomes

  1. Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level

    Time frame: From first dose up to 21 days repeated cycles

  2. Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level

    Time frame: From first dose up to 21 days repeated cycles

  3. Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.

    Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)

  4. Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)

Sponsors and collaborators

Lead sponsor

iTeos Therapeutics

Industry

Registry information

Official study title

A First-in-Human Open-label, Phase I Dose Escalation and Expansion Cohort Study of EOS301984 as Monotherapy and in Combination With Other,Anticancer Treatments in Participants With Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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