Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
NCT06686394 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81
Last updated 2026-05-22
Summary
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
Conditions
- Breast Neoplasms
- Breast Cancer
Interventions
- BIOLOGICAL
-
Patritumab deruxtecan administered via IV infusion
- BIOLOGICAL
-
Trastuzumab administered via IV infusion
- BIOLOGICAL
-
Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
- BIOLOGICAL
-
Pertuzumab administered via IV infusion
- BIOLOGICAL
-
Tucatinib administered as oral tablets
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-26
- Primary Completion
- 2030-04-18
- Completion
- 2030-04-18
- FDA Drug
- Yes
Countries
- United States
- Canada
- Israel
- Japan
- South Korea
- United Kingdom
Study Locations
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