Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06223542

Studying TAK-243 in Patients With Advanced Cancer

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

95

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Studying TAK-243 in Patients With Advanced Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed advanced or metastatic solid tumors with relapsed or refractory disease who have received standard therapies, or patients with aggressive lymphomas treated with 2 or more prior therapies without effective options
  • Measurable or evaluable disease
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Hemoglobin level of 9 g/dL or higher (transfusions allowed)
  • Absolute neutrophil count of at least 1000/mcL
  • Platelet count of at least 75,000/mcL
  • Total bilirubin at or below 1.5 times institutional upper limit of normal (ULN)
  • AST/ALT at or below 3 times ULN, or 5 times ULN if liver metastases present
  • Creatinine at or below 1.5 times ULN or creatinine clearance of 60 mL/min/1.73 m2 or higher
  • Completed prior therapies at least 4 weeks or 5 half-lives before enrollment
  • Female patients must be postmenopausal, surgically sterile, or agree to use effective contraception
  • Male patients must agree to use effective barrier contraception or abstinence during and 4 months after study
  • Ability to understand and provide informed consent
  • Willingness to provide blood samples for research
  • Willingness to undergo 2 core needle biopsies if applicable during expansion phase
  • Patients on anticoagulation allowed if no drug interactions with TAK-243
Not Eligible

You will not qualify if you...

  • Receiving other investigational agents
  • Uncontrolled illness including active infection or psychiatric/social issues limiting compliance
  • Life-threatening illness unrelated to cancer
  • Uncontrolled coagulopathy or bleeding disorder
  • Known liver cirrhosis or severe liver impairment
  • Significant heart or lung diseases including unstable angina, severe heart failure, recent myocardial infarction, cardiomyopathy, or significant arrhythmias
  • Prolonged QTc interval (≥470 msec)
  • Uncontrolled high blood pressure
  • Moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis
  • Major surgery within 14 days prior to first dose
  • Women intending to donate eggs or men intending to donate sperm during study or 4 months after
  • Known brain metastases except stable disease after treatment for at least 1 month
  • Use of strong CYP3A4/5 inhibitors or inducers and strong inhibitors of BCRP or OATP from 14 days before enrollment through study
  • Use of herbal medications except vitamins during treatment
  • Vaccination with live vaccines within 30 days before or during study and for 100 days after last dose
  • History of allergic reaction to similar compounds
  • Untreated or uncontrolled hepatitis B or C infection
  • HIV-positive patients must meet specific immune and treatment criteria
  • Pregnant or breastfeeding women due to potential risks of TAK-243

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States, 20892

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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