Sacituzumab Tirumotecan for Anal Cancer

Overseen By Van Morris, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Severe dry eye, IBD, cardiovascular disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression or withdrawal

What You Need to Know Before You Apply

What is the purpose of this trial?

To look at the effectiveness of sacituzumab tirumotecan (MK-2870) in treating participants with treatment-refractory unresectable and/or metastatic anal/rectal cancer.

Who Is on the Research Team?

Van Morris, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Phase 2: Treatment with Sacituzumab Tirumotecan Experimental Treatment 1 Intervention

Treatment with sacituzumab tirumotecan will occur until clinical or radiographic progression,unacceptable toxicity, withdrawal of consent for study participation.

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

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