RecruitingPhase 1Phase 2NCT05204862

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


Sponsor

TiumBio Co., Ltd.

Enrollment

240 participants

Start Date

Dec 2, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anti-PD-1 antibody and a drug called TU2218 for people with advanced solid tumor. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTU2218

orally administered

DRUGAnti-PD-1 antibody

Intravenously administered


Locations(3)

NEXT Oncology

San Antonio, Texas, United States

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05204862


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