TAK-243 for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of 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.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking certain medications, specifically strong inhibitors and inducers of CYP3A4/5, as well as strong inhibitors of BCRP or OATP, 14 days before joining and throughout the study. Herbal medications are also not allowed, except for vitamins. It's important to discuss your current medications with the trial team to ensure there are no interactions with TAK-243.
Who Is on the Research Team?
Sarah Shin, MD
Principal Investigator
National Cancer Institute LAO
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors that have worsened after treatment, or lymphoma patients without curative options. Participants must be in relatively good health (ECOG <=2), have measurable disease, and meet specific blood and organ function criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive UAE inhibitor TAK-243 intravenously on a dose-escalation schedule, with Arm A receiving doses on days 1, 4, 8, and 11 of a 21-day cycle, and Arm B receiving doses on days 1, 8, and 15 of a 28-day cycle. Patients also undergo biopsy, CT, MRI, and blood collection throughout the study.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, including assessment of objective tumor response and pharmacodynamic variables.
What Are the Treatments Tested in This Trial?
Interventions
- TAK-243
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor