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MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer

MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer

NCT01097460•Merrimack Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

Detailed Description

Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and the recommended Phase 2 dose will be determined.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)
•Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy
•The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes
•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 (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1)
•Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).
•Patients should have a life expectancy of at least 12 weeks
•Patients must have adequate bone marrow reserves
•Patients must have adequate hepatic function
+3 more criteria

Exclusion Criteria

•Patients who are pregnant or lactating
•Patients with an active infection or with an unexplained fever \> 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing.
•Patients with untreated and/or symptomatic metastatic CNS malignancies.
•Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin.
•Patients who have received other recent antitumor therapy including:
•* Treatment with Herceptin within the 28 days prior to the first scheduled day of dosing with MM-111
•* Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed.)
•* Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111
•Patients who have previously received MM-111
•Patients with NYHA Class III or IV congestive heart failure or LVEF \< 50%
+3 more criteria

Locations (3)

Indiana University (IUPUI)

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

January 7, 2015

Enrollment

ACTUAL participants

Conditions

Breast Neoplasms

Interventions

MM-111 + Herceptin

DRUG

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

RECRUITINGPHASE2

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635

Breast NeoplasmsBreast Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B