Advanced Solid Tumors
Conditions
Keywords
Advanced solid tumors, neoplasm, cancer, phase I, immunotherapy, anticancer
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.
Interventions
DRUGEOS301984
Multiple doses of EOS301984
DRUGAnti-PD-1 monoclonal antibody
Multiple doses of EOS301984 in combination with Anti-PD-1
Sponsors
iTeos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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) |
Countries
Belgium
Outcome results
None listed