Studying TAK-243 in Patients With Advanced Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

Patients with histologically documented advanced or metastatic solid tumors with relapsed or refractory disease who have received standard-of-care or approved therapies known to confer clinical benefit, or patients with aggressive lymphomas who have received ≥ 2 prior lines of lymphoma-directed therapy and who do not have remaining effective treatment options (including transplant). Additionally, patients with indolent lymphomas must meet criteria for treatment.

Patients must have measurable or evaluable disease

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Disqualifiers

Patients who are receiving any other investigational agents

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements

Life-threatening illness unrelated to cancer

Patients with uncontrolled coagulopathy or bleeding disorder

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • UAE Inhibitor TAK-243

Treatment groups

95 Participants
are divided into 2 treatment groups