20 Participants NeededMy employer runs this trial

Sacituzumab Tirumotecan for Renal Medullary Carcinoma

PM
Overseen ByPavlos Msaouel, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial aims to determine if the drug sacituzumab tirumotecan can help manage advanced or metastatic renal medullary carcinoma (RMC), a rare kidney cancer, in patients whose disease has worsened after at least one previous treatment. The study involves a single group of participants receiving this experimental drug. It suits individuals diagnosed with advanced RMC (confirmed through specific lab tests) who have experienced disease progression despite prior treatment. Participants should also have measurable cancer areas that can be tracked with imaging techniques like MRI or CT scans. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving anticancer therapies or have received them within 2 weeks before the study starts.

Is there any evidence suggesting that sacituzumab tirumotecan is likely to be safe for humans?

Research shows that sacituzumab tirumotecan is generally well-tolerated. Earlier studies reported mostly mild side effects, such as nausea and hair loss. Some participants experienced more serious side effects, like low white blood cell counts, which can weaken the immune system and hinder infection-fighting. However, these side effects were manageable.

Sacituzumab tirumotecan has also been tested in other cancer types, and the treatment proved safe for most participants, causing no severe or unexpected problems. While these results are promising, individual reactions can vary. Prospective trial participants should consult a healthcare provider to understand the potential risks and benefits.12345

Why do researchers think this study treatment might be promising?

Sacituzumab Tirumotecan is unique because it combines an antibody with a cancer-killing drug, specifically designed to target renal medullary carcinoma cells. This treatment offers a novel approach compared to the current standard therapies like chemotherapy, which often impact healthy cells as well. By directly delivering the drug to cancer cells, Sacituzumab Tirumotecan may reduce side effects and improve effectiveness. Researchers are excited about this treatment because it represents a more targeted strategy, potentially leading to better outcomes for patients with this rare and aggressive type of kidney cancer.

What evidence suggests that sacituzumab tirumotecan might be an effective treatment for renal medullary carcinoma?

Research has shown that sacituzumab tirumotecan could be a promising treatment for renal medullary carcinoma (RMC). This drug targets TROP2, a protein abundantly present in RMC cells, making it an effective treatment target. A similar drug, sacituzumab govitecan, demonstrated potential benefits in earlier studies, suggesting that sacituzumab tirumotecan might also be effective. Early findings indicate that this drug may help manage advanced or spreading RMC, particularly in patients unresponsive to other treatments. Although more research is needed, the initial results offer hope for those facing this challenging condition.12567

Who Is on the Research Team?

PM

Pavlos Msaouel, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic SMARCB1-deficient renal medullary carcinoma whose cancer has worsened after at least one prior treatment. Participants must be able to move around, have measurable disease, and meet basic blood and organ function requirements.

Inclusion Criteria

I am at least 18 years old.
I have tried at least one previous treatment, but my disease has worsened.
I use a wheelchair but can move around independently.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan for advanced or metastatic SMARCB1-deficient RMC

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Monitoring for safety and adverse events through study completion

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Sacituzumab Tirumotecan

Trial Overview

The study is testing sacituzumab tirumotecan, a new drug, to see if it can help control kidney cancer that has progressed despite previous treatments. All participants receive this medication in a phase II clinical trial setting.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41172996/

Identification of therapeutic targets for renal medullary ...

Sacituzumab govitecan demonstrates potential clinical benefit, warranting further evaluation in prospective trials to confirm its efficacy and ...

Phase II Trial of Sacituzumab Tirumotecan in ...

To learn if sacituzumab tirumotecan can help to control advanced or metastatic SMARCB1-deficient RMC in patients whose disease has progressed after receiving at ...

Comprehensive molecular profiling of renal medullary ...

Comprehensive molecular profiling of renal medullary carcinoma identifies TROP2 as a promising therapeutic target. MD Anderson Research News ...

From Clinical Trials to Real Impact: Expanding Treatment ...

These expanding studies and therapeutic avenues have already led to measurable improvements in patient outcomes. Another important advancement ...

Sacituzumab Tirumotecan for Renal Medullary Carcinoma

... Sacituzumab Tirumotecan will have tolerable side effects & efficacy for patients with Renal Medullary Carcinoma, Middle stage, Breast cancer and Topotecan ...

Sacituzumab Tirumotecan in Recurrent/Metastatic Adenoid ...

This is an open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab Tirumotecan (sac-TMT) ...

Sacituzumab tirumotecan (sac-TMT/MK-2870/SKB264)

The safety profile of sac-TMT seems easily manageable; adverse events include mainly grade 1/2 nausea and alopecia, while grade 3/4 neutropenia and leukopenia ...