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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: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by TiumBio Co..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD is determined as DLTs.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2021-12-02 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT05204862 shows while recruiting
NCT05204862 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (25% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05204862's enrollment target sits among peer trials
240 49th of 189 higher than 139 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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