Studying TAK-243 in Patients With Advanced Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06223542
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Lymphoma
  • Advanced Malignant Solid Neoplasm
  • Indolent Non-Hodgkin Lymphoma
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Refractory Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • UAE Inhibitor TAK-243 — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Apr 2026
Primary completion
Apr 15, 2027
Completion
Apr 15, 2027

Study Design

Enrollment
95 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (twice weekly UAE inhibitor TAK-243)
    Patients receive UAE inhibitor TAK-243 IV on days 1, 4, 8, and 11 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study, and undergo CT, MRI, and collection of blood throughout the study, and may undergo ECHO as clinically indicated on study.
  • Experimental: Arm B (once weekly UAE inhibitor TAK-243)
    Patients receive UAE inhibitor TAK-243 IV on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study, and undergo CT, MRI, and collection of blood throughout the study, and may undergo ECHO as clinically indicated on study.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Within the first cycle of treatment (Arm A: 21-day cycle; Arm B: 28-day cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
Sarah Shin (PRINCIPAL_INVESTIGATOR)

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By research site
National Cancer Institute Developmental Therapeutics Clinic· Bethesda, MD

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