Clinical trial NCT00911898: A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
Official title: A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Her2 Amplified Solid Tumors
Metastatic Breast Cancer
Keywords: Her2 amplified solid tumors
Breast Cancer
Her3/ErbB3
Bispecific Antibody
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label Phase 1 trial of MM-111.

Detailed description: Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
timeFrame: 28 days
Secondary outcomes:
measure: 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)
timeFrame: December 2011
measure: To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity
timeFrame: December 2011
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Norris Comprehensive Cancer Center
state: California
city: Indianapolis
country: United States
facility: Indiana University (IUPUI)
state: Indiana
city: Philadelphia
country: United States
facility: Fox Chase Center
state: Pennsylvania
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: The START Center for Cancer Care
name: Muralidhar Beeram, MD
role: PRINCIPAL_INVESTIGATOR
References: