A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
TiumBio Co., Ltd.
Summary
This study consists of phase 1b and 2a to evaluate safety, Pharmacokinetics, and efficacy of TU2218 in combination with Pembrolizumab in patients with advanced solid tumors.
Description
The primary objective of phase 1b is to determine the recommended phase 2 dose of the combination (RP2DC) of TU2218 given with pembrolizumab in advanced solid tumors. The primary objective of phase 2a is to evaluate the efficacy of TU2218 administered in combination with pembrolizumab in selected advanced tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and females ≥18 years of age 2. Life expectancy ≥12 weeks as judged by the Investigator 3. Measurable disease as defined by RECIST v1.1 4. ECOG 0 or 1 5. Able to swallow capsules 6. For Phase 1b and 2a: histologically or cytologically documented advanced unresectable solid tumor for which no effective standard therapy exists, or that has progressed on or not tolerated prior standard therapy. If previously treated with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, PD-1 treatment progres…
Interventions
- DrugTU2218 + KEYTRUDA® (Pembrolizumab)
TU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered
Locations (11)
- NEXT OncologySan Antonio, Texas
- Hope Cancer CenterTyler, Texas
- Medical OncologySpokane, Washington
- CHA University Bundang Medical CenterSeongnam
- Seoul National University Bundang HospitalSeongnam
- Asan Medical CenterSeoul