Patritumab Deruxtecan for Breast Cancer

Recruiting at 9 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Anti-HER2 therapy

Must not be taking: HER2-targeted tyrosine kinase inhibitors

Disqualifiers: Cardiovascular disease, Pneumonitis, Respiratory compromise, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to approximately 12 months

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

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 individuals with HER2 positive breast cancer that's spread and can't be surgically removed. Participants must have had disease progression after T-DXd treatment, not more than 5 prior anti-HER2 therapies, no history of certain HER2-targeted treatments, controlled HIV or hepatitis if present, and an ECOG performance status of 0 to 1.

Inclusion Criteria

I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.

My cancer got worse after treatment with T-DXd.

I have had 5 or fewer previous HER2 treatments for advanced cancer.

Exclusion Criteria

I have serious heart problems that are not under control.

I have or had lung inflammation needing steroids.

I have never had leptomeningeal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive patritumab deruxtecan with other anticancer agents in 21-day cycles until disease progression, intolerable toxicity, or investigator decision

Up to approximately 12 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Monitoring

Blood samples collected at designated time points to determine pharmacokinetics of patritumab deruxtecan

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Patritumab deruxtecan

Trial Overview The study tests patritumab deruxtecan combined with other anticancer agents in treating advanced HER2 positive breast cancer. It aims to assess the safety, tolerability, and effectiveness in reducing or eliminating cancer.

How Is the Trial Designed?

Group I: Patritumab deruxtecan plus trastuzumab and tucatinib Experimental Treatment 4 Interventions

Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.

Group II: Patritumab deruxtecan plus trastuzumab Experimental Treatment 3 Interventions

Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.

Group III: Patritumab deruxtecan plus pertuzumab and trastuzumab Experimental Treatment 4 Interventions

Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.

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

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD