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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: EOS301984; Drug: Anti-PD-1 monoclonal antibody

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium, 1070
    • Institut Jules Bordet
  • Charleroi, Belgium, 6060
    • Grand Hôpital de Charleroi
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Liège, Belgium, 4000
    • CHU de Liège
  • Wilrijk, Belgium, 2610
    • GZA Ziekenhuizen campus Sint-Augustinus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A dose escalation; EOS301984 dose escalation as monotherapy	Drug: EOS301984; Multiple doses of EOS301984; Other Names: EOS-984
Experimental: Part 1B dose escalation; EOS301984 in combination with other cancer therapies	Drug: EOS301984; Multiple doses of EOS301984; Other Names: EOS-984; Drug: Anti-PD-1 monoclonal antibody; Multiple doses of EOS301984 in combination with Anti-PD-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors	From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984	From first study treatment administration to last participant last follow-up (Up to 4 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level	From first dose up to 21 days repeated cycles
Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level	From first dose up to 21 days repeated cycles
Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.	From first study treatment administration to last participant last follow-up (Up to 4 years)
Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	From first study treatment administration to last participant last follow-up (Up to 4 years)

Collaborators and Investigators

• Sponsor: iTeos Therapeutics
• Investigators: Study Director: Iteos Clinical Trials, iTeos Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: immunotherapy; cancer; phase I; neoplasm; Advanced solid tumors; anticancer
• Additional Relevant MeSH Terms: Neoplasms; Immunologic Factors; Physiological Effects of Drugs; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: APT-008; 2023-503844-14-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No