Status:
ACTIVE_NOT_RECRUITING
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
Lead Sponsor:
iTeos Therapeutics
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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.
Exclusion
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06547957
Start Date
July 7 2023
End Date
December 1 2025
Last Update
August 13 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Jules Bordet
Brussels, Belgium, 1070
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
3
Grand Hopital de Charleroi
Charleroi, Belgium, 6060
4
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000