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

NCT06547957 | Active Not Recruiting Phase 1

• 2 other identifiers: APT-0082023-503844-14-00
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

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

Keywords

Advanced solid tumors; neoplasm; cancer; phase I; immunotherapy; anticancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (2)

Part 1A dose escalation

EXPERIMENTAL

EOS301984 dose escalation as monotherapy

Drug: EOS301984

Part 1B dose escalation

EXPERIMENTAL

EOS301984 in combination with other cancer therapies

Drug: EOS301984; Drug: Anti-PD-1 monoclonal antibody

Interventions

EOS301984 DRUG

Multiple doses of EOS301984

Also known as: EOS-984

Part 1A dose escalation; Part 1B dose escalation

Anti-PD-1 monoclonal antibody DRUG

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

Part 1B dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iTeos Therapeutics: lead

Study Sites (6)

Institut Jules Bordet

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hopital de Charleroi

Charleroi, 6060, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

GZA Ziekenhuizen campus Sint-Augustinus

Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

spartalizumab

Study Officials

• Iteos Clinical Trials

  iTeos Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: August 9, 2024
• Study Start: July 7, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)