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NCT06223542 · ClinicalTrials.gov registry record · Phase 1

Studying TAK-243 in Patients With Advanced Cancer

A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
95
Enrollment target
1
Study location

NCT06223542: Recruiting Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).

NCT06223542 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 95 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06223542, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
95 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the side effects and best dose of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (TAK-243) in treating patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) and in patients with lymphoma. TAK-243 is a drug that binds to and inhibits the ubiquitin-activating enzyme, an enzyme that is more active on cancer cells than healthy cells, inhibiting tumor cell proliferation and survival.

Primary Outcome

The MTD for each arm will be based on the assessment of dose-limiting toxicities (DLTs) and will be defined as the dose level at which less than one-third of patients (\< 2/6 patients) treated at that dose experience a DLT, with the next higher dose level demonstrating a one-third or greater number of patients (\>= 2/3 or \>= 2/6 patients) having DLT.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • PROCEDURE Echocardiography Test

Study Locations (1)

Maryland

  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2025-03-24
Est. Completion 2026-04-15
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06223542 shows while recruiting

NCT06223542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (46% lower).

The record links to 6 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06223542 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT06223542 about?

NCT06223542 is a clinical study titled "Studying TAK-243 in Patients With Advanced Cancer". This phase I trial studies the side effects and best dose of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (TAK-243) in treating patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has sprea...

What is the current status of trial NCT06223542?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2025-03-24. Estimated completion is 2026-04-15.

What conditions does trial NCT06223542 study?

This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Advanced Lymphoma.

What interventions are being tested in trial NCT06223542?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE).

Who is sponsoring clinical trial NCT06223542?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06223542 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Malignant Solid Neoplasm

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 NCT06223542's enrollment target sits among peer trials

95 25th of 108 higher than 84 of 108 other Advanced Malignant Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm 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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Source: ClinicalTrials.gov NCT06223542, the US trial registry maintained by the National Library of Medicine. NCT06223542 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.