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RECRUITING Phase 1

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

NCT05204862 · View on ClinicalTrials.gov ↗

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

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.

33 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TiumBio Co., which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05204862 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05204862?

The interventions under investigation include: TU2218 (DRUG), Anti-PD-1 antibody (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05204862?

This trial is sponsored by TiumBio Co., which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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