A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Inupadenant
- Conditions
- Solid Tumor, Adult
- Sponsor
- iTeos Therapeutics
- Enrollment
- 64
- Locations
- 5
- Primary Endpoint
- Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
A Multicenter, Open-Label, Phase I Clinical Study to assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants with Advanced Solid Tumors
Investigators
Eligibility Criteria
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/exclusion criteria could apply
Arms & Interventions
Inupadenant sequential dose escalation (Part 1A)
Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors.
Intervention: Inupadenant
Inupadenant randomized crossover (Part 1B)
The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors.
Intervention: Inupadenant
Inupadenant single treatment assignment (Part 1C)
Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors.
Intervention: Inupadenant
Outcomes
Primary Outcomes
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
Time Frame: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)
Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities
Incidence and severity of AEs in patients receiving inupadenant
Time Frame: Through study completion, an average of 4 months
To assess safety and tolerability as measured by incidence and severity of AEs
Secondary Outcomes
- Plasma concentration of inupadenant vs. time profiles(Through study completion, an average of 4 months)
- Maximum observed serum concentration (Cmax)(Through study completion, an average of 4 months)
- Time of maximum observed concentration (Tmax)(Through study completion, an average of 4 months)
- Area under the concentration-time curve in 1 dosing interval [AUC(TAU)](Through study completion, an average of 4 months)
- Plasma concentration half-life (T-HALF)(Through study completion, an average of 4 months)
- Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1(Through study completion, an average of 4 months)