Sacituzumab Tirumotecan for Anal Cancer

VM
Overseen ByVan Morris, 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 trial tests a treatment called sacituzumab tirumotecan, a type of cancer therapy, to determine its effectiveness for anal or rectal cancer that is inoperable or has metastasized. The main goal is to assess its efficacy in patients whose cancer has not responded to other treatments. This study may suit individuals who have tried up to three different cancer treatments without success. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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 take strong inhibitors or inducers of the CYP3A4 enzyme within 2 weeks before starting the study and during the treatment. It's best to discuss your current medications with the study team.

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

Research has shown that sacituzumab tirumotecan generally has a manageable safety profile. Patients with advanced solid tumors, including anal cancer, have mostly tolerated this treatment well. One study found that the side effects were controllable and not too severe. Another study confirmed that researchers tested this drug safely in people before. While no treatment is without risk, the data so far suggest that sacituzumab tirumotecan is relatively well-tolerated in this setting.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for anal cancer, which typically include chemotherapy and radiation, Sacituzumab Tirumotecan is a new type of drug that combines an antibody with a chemotherapy agent. This combination allows it to specifically target and deliver the chemotherapy directly to cancer cells, potentially increasing effectiveness while reducing side effects. Researchers are excited about its unique mechanism of action, which targets the Trop-2 protein often overexpressed in cancer cells, offering hope for improved outcomes in patients where traditional therapies have limited success.

What evidence suggests that sacituzumab tirumotecan might be an effective treatment for anal cancer?

Research has shown that sacituzumab tirumotecan holds promise for treating various cancers, including anal cancer. Studies indicate that it helps patients live longer and slows cancer progression compared to other treatments. Patients with high levels of the protein Trop-2, associated with tumor growth, experienced better survival rates. The treatment also presents manageable side effects and has demonstrated strong effects against advanced solid tumors. Overall, early findings suggest that sacituzumab tirumotecan could be a viable option for hard-to-treat cancers.12367

Who Is on the Research Team?

VM

Van Morris, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with squamous cell carcinoma of the anus or rectum that has spread or can't be removed by surgery, who have already tried 1-3 types of prior treatments. Participants must have measurable disease and be in good physical condition. Effective birth control is required during and after treatment.

Inclusion Criteria

9\. Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.
I use highly effective birth control or am long-term abstinent, and I will not donate or store eggs during and for 210 days after treatment.
I have advanced squamous cell cancer of the anus or rectum that cannot be removed by surgery.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sacituzumab Tirumotecan until clinical or radiographic progression, unacceptable toxicity, or withdrawal of consent

Until progression or withdrawal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sacituzumab Tirumotecan

Trial Overview

The study tests sacituzumab tirumotecan, a new drug, to see how well it works for people whose anal or rectal cancer hasn't responded to previous treatments. All participants receive this medication.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Phase 2: Treatment with Sacituzumab TirumotecanExperimental 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

Sacituzumab tirumotecan (Sac-TMT) plus pembrolizumab ...

Conclusions: Sac-TMT + pembro showed promising antitumor activity at both 4 and 5 mg/kg in previously untreated, cisplatin-ineligible pts with ...

Sacituzumab Tirumotecan for Anal Cancer

... Sacituzumab Tirumotecan will have tolerable side effects & efficacy for patients with Breast cancer, Cancer, Esophageal cancer, Anal Cancer ...

Sacituzumab Tirumotecan: Clinical Development, ...

The results of OptiTROP-Breast02 demonstrated that sacituzumab tirumotecan significantly improved progression-free survival and objective ...

The Mode of Action and Clinical Outcomes of Sacituzumab ...

The median overall survival was 14.2, 14.9, and 9.3 months with SG versus 6.9, 6.9, and 7.6 months with TPC in patients with high, medium, and low Trop-2 scores ...

NCT06428409 | A Clinical Study of MK-2870 Alone or With ...

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers.

Sacituzumab Tirumotecan Shows Promising Antitumor ...

A phase 1/2 trial reveals sacituzumab tirumotecan shows manageable toxicity and promising antitumor activity in patients with advanced solid ...

Efficacy and safety of sacituzumab govitecan Trop-2- ...

Our systematic review and meta-analysis confirmed that SG confers good clinical activity in certain solid tumor types and was tolerable with minimal adverse ...