Solid Tumor, Adult
Conditions
Keywords
solid, tumor, advanced cancers, pharmacokinetics, safety, inupadenant, pembrolizumab, chemotherapy
Brief summary
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
Interventions
DRUGEOS100850
Oral administration
DRUGPembrolizumab
IV Infusion
DRUGChemotherapy
Standard of Care IV Infusion
Sponsors
iTeos Belgium SA
Merck Sharp & Dohme LLC
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
For more information regarding participation in the Trial, please refer to your physician Inclusion Criteria: * Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available. * At least 4 weeks since any previous treatment for cancer * Subject must consent to pretreatment and on treatment tumor biopsies * Adequate organ and marrow function
Exclusion criteria
* Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted * Participants with second/other active cancers requiring current treatment * Uncontrolled/significant heart disease * Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS) * Active/uncontrolled autoimmune disease * Active infection Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 | During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks) | To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850 |
| Incidence and severity of AEs in patients receiving EOS100850 | Up to 30 months | To assess safety and tolerability as measured by incidence and severity of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum observed concentration (Tmax) | Up to 30 months | Determined by inspection of the concentration-time profile |
| Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] | Up to 30 months | Determined by inspection of the concentration-time profile |
| Plasma concentration of EOS100850 vs. time profiles | Up to 30 months | Determined by inspection of the concentration-time profile |
| Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 | Up to 30 months | Assessment of preliminary efficacy of EOS100850 |
| Plasma concentration half-life (T-HALF) | Up to 30 months | Determined by inspection of the concentration-time profile |
| Maximum observed serum concentration (Cmax) | Up to 30 months | Determined by inspection of the concentration-time profile |
Countries
Belgium, France, South Korea, Spain, United Kingdom, United States
Outcome results
None listed