A Phase 1/2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Inhibitor, Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
TiumBio Co., Ltd.
Summary
This study consists of Part A for monotherapy and Part B for combination therapy to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of TU2218 in patients with advanced solid tumors. The main purpose of Phase 1 is to determined the recommended Phase 2 dose (RP2D) of TU2218 and the main purpose of Phase 2 is to evaluate the antitumor activity of TU2218 at RP2D.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females at least 18 years of age at the time of consent (ie, screening), or according to local regulatory requirement if the legal age for consenting for study participation is more than 18 years. * Life expectancy ≥12 weeks as judged by the Investigator. * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; except for Phase1a that can enroll patients with either measurable and/or non-measurable disease. * Eastern Cooperative Oncology Group (ECOG) 0 or 1. * Able to swallow capsules. * Histologically or cytological…
Interventions
- DrugTU2218
orally administered
- DrugAnti-PD-1 antibody
Intravenously administered
Locations (3)
- NEXT OncologySan Antonio, Texas
- Seoul National University HospitalSeoul
- Asan Medical CenterSeoul