Sacituzumab Tirumotecan for Bladder Cancer

(TroFuse-027 Trial)

Recruiting at 14 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: High-grade NMIBC, MIBC, Metastatic UC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Sacituzumab Tirumotecan for individuals with a specific type of bladder cancer. Researchers aim to determine the treatment's safety and the maximum dosage that can be administered without causing excessive side effects. The trial targets individuals with non-muscle invasive bladder cancer that has recurred and does not respond well to other treatments. Participants should have had visible tumors detected in the bladder through a procedure called cystoscopy within the past 12 weeks. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Sacituzumab Tirumotecan is likely to be safe for humans?

Research shows that sacituzumab tirumotecan is being tested for safety and patient tolerance, particularly when administered directly into the bladder. In a study involving individuals with advanced bladder cancer, sacituzumab tirumotecan demonstrated a manageable safety profile. While some side effects occurred, they were generally mild and manageable.

Researchers continue to test the treatment to determine the highest dose with minimal issues, ensuring safety before wider use. Although still in early research stages, previous studies suggest it is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Unlike the standard treatments for bladder cancer, which typically involve chemotherapy or immunotherapy, Sacituzumab Tirumotecan offers a novel approach by using an antibody-drug conjugate. This treatment combines an antibody that specifically targets cancer cells with a potent chemotherapy agent, delivering the drug directly to the tumor. This targeted delivery may enhance the effectiveness of the drug while reducing side effects compared to traditional chemotherapy. Researchers are excited about this treatment's potential to improve outcomes for patients with bladder cancer by offering a more precise and potentially more tolerable therapy.

What evidence suggests that Sacituzumab Tirumotecan might be an effective treatment for bladder cancer?

Research has shown that Sacituzumab Tirumotecan, the investigational treatment in this trial, may help treat urothelial carcinoma, a type of bladder cancer. Studies have found that treatments targeting TROP2, a protein often found in large amounts on cancer cells, can be effective for patients with advanced bladder cancer. Sacituzumab Tirumotecan, which blocks TROP2, showed positive results and manageable side effects in these patients. While researchers continue to collect more data, this treatment aims to deliver chemotherapy directly to cancer cells, potentially reducing side effects and improving outcomes. Early findings suggest this method could be beneficial for treating bladder cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for people with recurrent low-grade bladder cancer that hasn't spread into muscle. They should have had a tumor seen by cystoscopy within the last 12 weeks, possibly multiple tumors or frequent recurrences, and may have failed previous treatments. Participants need to be relatively active and well (ECOG status 0-2).

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My tumor is larger than 3 cm and it's the only one.

My previous bladder treatments did not work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks

6 weeks

Dose Limiting Toxicity Evaluation

Evaluation of dose limiting toxicity during the treatment period

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Monitoring of complete response and adverse events over an extended period

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Tirumotecan

Trial Overview Researchers are testing Sacituzumab Tirumotecan given directly in the bladder to find a safe and tolerable dose. This chosen dose will then be used in future studies to see how effective it is against bladder cancer.

How Is the Trial Designed?

Group I: Sacituzumab tirumotecan Experimental Treatment 3 Interventions

Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

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

Published Research Related to This Trial

In a phase II study involving 113 patients with metastatic urothelial carcinoma who had previously progressed on platinum-based chemotherapy and checkpoint inhibitors, sacituzumab govitecan (SG) demonstrated an objective response rate of 27%, indicating significant efficacy in this difficult-to-treat population.

SG was associated with a manageable safety profile, with the most common severe side effects being neutropenia (35%) and diarrhea (10%), leading to a 6% discontinuation rate due to treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. Tagawa, ST., Balar, AV., Petrylak, DP., et al.[2022]

Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, received accelerated approval in 2021 for treating locally advanced and metastatic urothelial carcinoma after prior chemotherapy, showing promising efficacy and safety in clinical trials.

Despite its effectiveness, responses to sacituzumab govitecan are not universal, highlighting the importance of understanding resistance mechanisms and identifying predictive biomarkers to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Therapy for Locally Advanced or Metastatic Urothelial Cancer (mUC): Therapeutic Potential of Sacituzumab Govitecan. Fontes, MS., Vargas Pivato de Almeida, D., Cavalin, C., et al.[2023]

A total of 1,884 adverse event reports related to sacituzumab govitecan were analyzed, identifying 114 adverse event signals, with most occurring within 30 days of treatment initiation, highlighting the importance of monitoring for early reactions.

Risk factors for hospitalization due to adverse events included being male and experiencing conditions like colitis, febrile neutropenia, and sepsis, indicating specific patient profiles that may require closer observation during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). Li, X., Zhang, L., Hu, S., et al.[2023]

Enfortumab vedotin and sacituzumab govitecan are novel antibody-drug conjugates that improve treatment options for patients with advanced bladder cancer after they have received platinum-based therapy and immune checkpoint inhibitors, with enfortumab vedotin showing improved overall survival.

Sacituzumab govitecan has a 27% response rate in treating advanced bladder cancer, highlighting its potential effectiveness, but careful consideration of the safety profiles of both agents is essential for optimizing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of enfortumab vedotin and sacituzumab govitecan in treatment of advanced bladder cancer. Hanna, KS., Larson, S., Nguyen, J., et al.[2022]

In a phase I trial involving 23 patients with metastatic urothelial carcinoma, the combination of sacituzumab govitecan (SG) and enfortumab vedotin (EV) demonstrated a high objective response rate of 70%, with three patients achieving complete responses.

The study identified a safe dose for further testing, with 78% of patients experiencing grade ≥3 adverse events, indicating that while the treatment is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Double Antibody Drug Conjugate (DAD) phase I trial: sacituzumab govitecan plus enfortumab vedotin for metastatic urothelial carcinoma. McGregor, BA., Sonpavde, GP., Kwak, L., et al.[2023]

In a study of 38 patients with invasive bladder cancer, concurrent radiotherapy and panitumumab after chemotherapy resulted in a low rate of severe toxicity (16%), comparable to historical rates for cisplatin and radiotherapy.

The treatment achieved a high complete remission rate of 94%, with promising bladder preservation outcomes, suggesting that this approach could be a viable alternative for bladder cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent Radiotherapy and Panitumumab after Lymph Node Dissection and Induction Chemotherapy for Invasive Bladder Cancer. Fransen van de Putte, EE., Pos, F., Doodeman, B., et al.[2019]

Sacituzumab govitecan (SG) is an effective treatment for locally advanced and metastatic urothelial cancer, showing a 27% objective response rate in the TROPHY-U-01 phase II trial.

While SG has common side effects like diarrhea and neutropenia, these can be managed with supportive care, and it has received accelerated approval for patients who have previously undergone platinum-based chemotherapy and PD-1 or PD-L1 inhibitor treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and emerging role of sacituzumab govitecan in the management of urothelial carcinoma. Mathew Thomas, V., Tripathi, N., Agarwal, N., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.796

Report from the phase 1/2 MK-2870-001 study. No treatment-related deaths were reported by safety data cutoff (May 21, 2024). Efficacy outcomes are shown in the Table. Conclusions: sac-TMT ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06637423

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in ... The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12533752/

Advances in antibody-drug conjugates for urothelial ... Although approximately 50% of patients had upper tract UC carcinoma, the outcomes were comparable between upper tract UC and urothelial bladder ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.5_suppl.796

Report from the phase 1/2 MK-2870-001 study. In patients (pts) with urothelial carcinoma (UC), treatment with the anti-TROP2 ADC sacituzumab govitecan led to treatment-related grade ≥3 ...

5. urotoday.com urotoday.com/conference-highlights/asco-2025/asco-2025-bladder-cancer/161034-asco-2025-trials-in-progress-intravesical-sacituzumab-tirumotecan-in-participants-with-intermediate-risk-non-muscle-invasive-bladder-cancer-the-phase-1-2-trofuse-027-study.html

ASCO 2025: Trials-in-Progress – Intravesical Sacituzumab ... Systemic TROP2 inhibitors have demonstrated efficacy and a manageable safety profile in participants with metastatic urothelial carcinoma ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06637423

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in ... The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest ...