Clinical trial NCT06547957: A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumors
neoplasm
cancer
phase I
immunotherapy
anticancer
Lead sponsor: iTeos Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
timeFrame: From first study treatment administration to last participant last follow-up (Up to 4 years)
measure: Incidence and severity of AEs in patients receiving EEOS301984
timeFrame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Secondary outcomes:
measure: Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level
timeFrame: From first dose up to 21 days repeated cycles
measure: Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level
timeFrame: From first dose up to 21 days repeated cycles
measure: Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.
timeFrame: From first study treatment administration to last participant last follow-up (Up to 4 years)
measure: Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liège
country: Belgium
facility: CHU de Liège
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen campus Sint-Augustinus
Study officials:
affiliation: iTeos Therapeutics Inc.
name: Iteos Clinical Trials
role: STUDY_DIRECTOR
References: