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NCT05204862 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by TiumBio Co..

Recruiting
Registry status
Phase 1
Development phase
240
Enrollment target
3
Study locations

NCT05204862 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by TiumBio Co.. The registered enrollment target is 240 participants, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (25% higher). The trial reports 3 study locations across 2 states.

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The verdict

NCT05204862, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by TiumBio Co..

RECRUITING
Registry status
Phase 1
Development phase
240 participants
Enrollment target
3
Study locations

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 Studied

Advanced Solid Tumor

Interventions

  • DRUG TU2218
  • DRUG Anti-PD-1 antibody

Study Locations (3)

Other

  • Seoul National University Hospital - Seoul
  • Asan Medical Center - Seoul

Texas

  • NEXT Oncology - San Antonio

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2021-12-02
Est. Completion 2027-09-30
Phase Phase 1

Sponsor

TiumBio Co.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05204862

The ClinicalTrials.gov registry entry for NCT05204862 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (25% higher). The listed sponsor is TiumBio Co., which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which TU2218 is the first listed.

NCT05204862 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.

Frequently Asked Questions

What is clinical trial NCT05204862 about?

NCT05204862 is a clinical study titled "Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors". 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 a...

What is the current status of trial NCT05204862?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2021-12-02. Estimated completion is 2027-09-30.

What conditions does trial NCT05204862 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT05204862?

The interventions under investigation include: TU2218 (DRUG), Anti-PD-1 antibody (DRUG).

Who is sponsoring clinical trial NCT05204862?

This trial is sponsored by TiumBio Co., which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05204862 being conducted?

This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.