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Phase II Study of Sacituzumab Tirumotecan for SMARCB1-Deficient Renal Medullary Carcinoma

This study is testing a drug called sacituzumab tirumotecan for people with advanced or metastatic SMARCB1-deficient renal medullary carcinoma (RMC), a rare kidney cancer. You may be able to join if your cancer has progressed after at least one previous treatment. Researchers want to see how safe sacituzumab tirumotecan is and how well it can shrink tumors or stop them from growing. They will also look at how long people live, how long they live without their cancer getting worse, and how long the treatment works. To join, your cancer must be confirmed as SMARCB1-deficient RMC. The study plans to enroll 20 participants.

Study design
This is a Phase II interventional study, meaning it tests a new treatment in a small group of people to see if it's safe and effective. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07438626

Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~20 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs).
Measured over Through study completion; an average of 1 year.

Conditions

Phase II
Sacituzumab
Tirumotecan
SMARCB1-deficient Renal Medullary Carcinoma

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NCT07438626

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pavlos Msaouel, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Pavlos Msaouel, MD
[email protected]
713-563-4585
Email the study team

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Eligibility criteria

Inclusion

Refrain from donating sperm
Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive metho as a condom may break or leak
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure. 14. Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Participants with HIV who have controlled infection (undetectable viral load with the exception of clinically insignificant blips and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.
Participants with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.
Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: Serum HBV DNA PCR should be tested and if it is above the limit of detection at screening then antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed every 12 months +/- 3 months.
Participants who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted. 9. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. 10. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 11. Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting. 12. Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Symptomatic congestive heart failure of New York heart Association Class III or IV
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled symptomatic cardiac arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.
Participants with a history of major psychiatric illness judged unable to fully understand the investigational nature of the study and the risks associated with the therapy. 13. Participants must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sacituzumab tirumotecan or that might affect the interpretation of the results of the study or render the participant at high risk from treatment complications. 14. Participants should not receive immunization with attenuated live vaccines within 30 days of planned start of study medication.

What this trial measures

  • Safety and adverse events (AEs).Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0