Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Merrimack Pharmaceuticals
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
Research Team
Eligibility Criteria
Inclusion Criteria
Locally advanced/unresectable or metastatic breast cancer
Eighteen years of age or above
Able to understand and sign an informed consent (or have a legal representative who is able to do so)
See 4 more
Treatment Details
Interventions
- Cyclophosphamide (Antineoplastic Agent)
- MM-302 (Antineoplastic Agent)
- Trastuzumab (Monoclonal Antibodies)
Participant Groups
4Treatment groups
Experimental Treatment
Group I: MM-302 in Combination with Trastuzumab q3wExperimental Treatment1 Intervention
Group II: MM-302 in Combination with Trastuzumab and CyclophosphamideExperimental Treatment1 Intervention
Group III: MM-302 in Combination with TrastuzumabExperimental Treatment1 Intervention
Group IV: MM-302Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San FranciscoSan Francisco, CA
University of IndianaIndianapolis, IN
Dana Farber Cancer CenterBoston, MA
Karmanos Cancer CenterDetroit, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Merrimack Pharmaceuticals
Lead Sponsor
Trials
29
Patients Recruited
2,600+