Patritumab Deruxtecan for Breast Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

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

Eligibility Criteria

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.

+6 more

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.

+10 more

Trial Timeline

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

Participant Groups

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.

3Treatment groups

Experimental Treatment

Group I: Patritumab deruxtecan plus trastuzumab and tucatinibExperimental Treatment4 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 trastuzumabExperimental Treatment3 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 trastuzumabExperimental Treatment4 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.