A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
Monotherapy
A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
1 other identifier
interventional
20
1 country
4
Brief Summary
This study is an open-label Phase 1 trial of MM-111.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2009
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedJanuary 13, 2015
December 1, 2014
2.8 years
June 2, 2009
February 28, 2014
December 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.
28 days
Secondary Outcomes (2)
To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)
December 2011
To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity
December 2011
Study Arms (1)
MM-111
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed advanced cancer that is:
- HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation
- Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory
- Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining
- Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.
- Patients must be \>= 18 years of age
- Patients or their legal representatives must be able to understand and sign an informed consent
- Patients may have measurable or non-measurable tumor(s)
- Patients should have ECOG Performance Score (PS) 0 or 1
- Patients must have adequate bone marrow reserves as evidenced by:
- Absolute neutrophil count (ANC) \>= 1,500/uL and
- Platelet count \>= 100,000/uL
- Hemoglobin \>= 9 g/dL
- Patients must have tumor tissue amenable to biopsy
- Patients must be willing to undergo biopsy prior to treatment to MM-111
You may not qualify if:
- Patients for whom potentially curative antineoplastic therapy is available
- Patients who are pregnant or lactating
- Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)
- Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
- Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)
- Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Indiana University (IUPUI)
Indianapolis, Indiana, 46268, United States
Fox Chase Center
Philadelphia, Pennsylvania, 19111, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Muralibhar Beeram
- Organization
- South Texas Accelerated Research Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Muralidhar Beeram, MD
The START Center for Cancer Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 3, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
January 13, 2015
Results First Posted
September 15, 2014
Record last verified: 2014-12