NCT05784688

Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: TiumBio Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor
• Biliary Tract Cancer
• Head and Neck Squamous Cell Carcinoma
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TU2218 + KEYTRUDA® (Pembrolizumab)	TU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered

Timeline

• Start date: 2023-03-10
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2023-03-27
• Last updated: 2025-03-30

Locations

11 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study