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NCT06686394 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 17
- Study locations
NCT06686394: Recruiting Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by Merck Sharp & Dohme.
NCT06686394 is a Phase 1 study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 81 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06686394, a Phase 1 study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 17
- Study locations
Study 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
Primary Outcome
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented.
Conditions Studied
Interventions
- BIOLOGICAL Trastuzumab
- BIOLOGICAL Patritumab deruxtecan
- BIOLOGICAL Pertuzumab
- BIOLOGICAL Trastuzumab Biosimilar
- BIOLOGICAL Tucatinib
Study Locations (17)
Other
- Rambam Health Care Campus ( Site 0011) - Haifa
- Rabin Medical Center ( Site 0012) - Petah Tikva
- Sheba Medical Center ( Site 0010) - Ramat Gan
- Seoul National University Hospital ( Site 0030) - Seoul
- Asan Medical Center ( Site 0031) - Seoul
Ontario
- Kingston General Hospital ( Site 0061) - Kingston
- Princess Margaret Cancer Centre ( Site 0001) - Toronto
Quebec
- Centre Hospitalier de l'Université de Montréal ( Site 0004) - Montreal
- Jewish General Hospital ( Site 0003) - Montreal
Massachusetts
- Dana-Farber Cancer Institute ( Site 0050) - Boston
New Jersey
- Rutgers Cancer Institute of New Jersey ( Site 0052) - New Brunswick
South Carolina
- Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) - Greenville
Virginia
- Inova Schar Cancer Institute ( Site 0051) - Fairfax
Aichi-ken
- Nagoya City University Hospital ( Site 0020) - Nagoya
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2025-02-26 |
| Est. Completion | 2030-04-18 |
| Phase | Phase 1 |
What NCT06686394 shows while recruiting
NCT06686394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT06686394 lists 17 locations in 11 states (Other, Ontario, Quebec).
Frequently Asked Questions
What is clinical trial NCT06686394 about?
NCT06686394 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT06686394?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2025-02-26. Estimated completion is 2030-04-18.
What conditions does trial NCT06686394 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms.
What interventions are being tested in trial NCT06686394?
The interventions under investigation include: Trastuzumab (BIOLOGICAL), Patritumab deruxtecan (BIOLOGICAL), Pertuzumab (BIOLOGICAL), Trastuzumab Biosimilar (BIOLOGICAL), Tucatinib (BIOLOGICAL).
Who is sponsoring clinical trial NCT06686394?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06686394 being conducted?
This trial has 17 study locations across Massachusetts, New Jersey, South Carolina, Virginia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06686394's enrollment target sits among peer trials
81 644th of 1224 higher than 577 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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