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

NCT ID: NCT06547957

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1A dose escalation

EOS301984 dose escalation as monotherapy

Group Type: EXPERIMENTAL

EOS301984

Intervention Type: DRUG

Multiple doses of EOS301984

Part 1B dose escalation

EOS301984 in combination with other cancer therapies

Group Type: EXPERIMENTAL

EOS301984

Intervention Type: DRUG

Multiple doses of EOS301984

Anti-PD-1 monoclonal antibody

Intervention Type: DRUG

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

Interventions

EOS301984

Multiple doses of EOS301984

Intervention Type: DRUG

Anti-PD-1 monoclonal antibody

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

Intervention Type: DRUG

Other Intervention Names

EOS-984

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iTeos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iteos Clinical Trials

Role: STUDY_DIRECTOR

iTeos Therapeutics Inc.

Locations

Institut Jules Bordet

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Grand Hopital de Charleroi

Charleroi, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

CHU de Liège

Liège, , Belgium

GZA Ziekenhuizen campus Sint-Augustinus

Wilrijk, , Belgium

Countries

Belgium

Other Identifiers

2023-503844-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

APT-008

Identifier Type: -

Identifier Source: org_study_id