Trials / Recruiting
RecruitingNCT05204862
Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- TiumBio Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TU2218 | orally administered |
| DRUG | Anti-PD-1 antibody | Intravenously administered |
Timeline
- Start date
- 2021-12-02
- Primary completion
- 2026-06-30
- Completion
- 2027-09-30
- First posted
- 2022-01-24
- Last updated
- 2023-04-03
Locations
3 sites across 2 countries: United States, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05204862. Inclusion in this directory is not an endorsement.