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Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors

NCT05204862 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-04-03

No results posted yet for this study

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

  • Advanced Solid Tumor

Interventions

DRUG

TU2218

orally administered

DRUG

Anti-PD-1 antibody

Intravenously administered

Sponsors & Collaborators

  • TiumBio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • TU2218 · TiumBio Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2026-06-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204862 on ClinicalTrials.gov