A Study Evaluating MM-310 in Patients With Solid Tumors

February 26, 2018 updated by: Merrimack Pharmaceuticals

A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors

MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid tumors. In the first part of the study, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in combination with other therapies will be assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Honor Health
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University California San Francisco
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have one of the following cancers, for which the patient has either received or been intolerant to all therapy known to confer clinical benefit

    • Urothelial carcinoma
    • Gastric/gastroesophageal junction/esophageal carcinoma (G/GEJ/E)
    • Squamous Cell Carcinoma of the Head and neck (SCCHN)
    • Ovarian cancer
    • Pancreatic ductal adenocarcinoma (PDAC)
    • Prostate adenocarcinoma (PAC)
    • Non-small cell lung cancer (NSCLC)
    • Small cell lung cancer (SCLC)
    • Triple negative breast cancer (TNBC)
    • Endometrial carcinoma
    • Soft tissue sarcoma subtypes except GIST, desmoid tumors and pleomorphic rhabdomyosarcoma
  • Able to provide informed consent, or have a legal representative able and willing to do so
  • ≥ 18 years of age
  • Availability of a cancerous lesion amenable to biopsy and willing to undergo a pre-treatment biopsy
  • ECOG Performance Status of 0 or 1

  • Adequate bone marrow reserve as evidenced by:

    • ANC > 1,500/µl (unsupported by growth factors) and
    • Platelet count > 100,000/µl
    • Hemoglobin > 9 g/dL
  • Patients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limits

  • Adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
    • Alkaline phosphatase ≤ 2.5 x ULN, unless the elevated alkaline phosphatase is due to bone metastasis.
    • In case alkaline phosphatase is >2.5 x ULN patients are eligible for inclusion if aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x ULN
  • Adequate renal function as evidenced by a serum/plasma creatinine < 1.5 x ULN
  • Recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy to CTCAE v4.03 grade 1, baseline or less, except for alopecia
  • Women of childbearing potential or fertile men and their partners must be willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 6 months following the last dose of MM-310.

Exclusion Criteria:

  • Prior treatment with docetaxel within 6 months of study enrollment
  • Pregnant or lactating
  • Treatment with systemic anticoagulation (e.g. warfarin, heparin, low molecular weight heparin, anti-Xa inhibitors, etc.) except aspirin
  • Any evidence of hematemesis, melena, hematochezia, ≥ grade 2 hemoptysis, or gross hematuria
  • Any history of hereditary bleeding disorders
  • Presence of an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled
  • Known CNS metastases
  • Known hypersensitivity to the components of MM-310, or docetaxel
  • Prior treatment with MM-310
  • Received treatment, within 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state and all prior clinically significant treatment related toxicities have resolved to Grade 1 or baseline
  • Received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (or have not yet recovered from any actual toxicities of the most recent therapy) prior to the first scheduled dose of MM-310
  • Received any anti-cancer drug known to have anti-VEGF/VEGFR activity within a period of 5 half-lives of this drug (e.g. 100 days for bevacizumab, 75 days for ramucirumab) prior to the first scheduled dose of MM-310
  • Clinically significant cardiac disease, including: NYHA Class III or IV congestive heart failure, unstable angina, acute myocardial infarction within six months of planned first dose, arrhythmia requiring therapy (including torsades de pointes, with the exception of extrasystoles, minor conduction abnormalities, or controlled and well treated chronic atrial fibrillation)
  • Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
  • Patients who received organ or allogeneic bone marrow or peripheral blood stem cell transplants
  • Chronic use of corticosteroids more than 10mg daily prednisone equivalent during the past 4 weeks prior to planned start of MM-310
  • Concomitant use of strong inhibitors of CYP3A
  • Patients with peripheral neuropathy of grade 2 or higher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MM-310 monotherapy
MM-310 will be administered by IV infusion over 90 minutes on the first day of each 21 day cycle.
Drug: MM-310
MM-310

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 18 months
18 months
Serum levels of analytes that comprise MM-310
Time Frame: 18 months
18 months
Adverse event profile using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time Frame: 18 months
18 months
Presence of human anti-human antibodies to MM-310
Time Frame: 18 months
18 months
Objective responses based on RECIST v1.1 or other relevant criteria
Time Frame: 18 months
18 months
Disease Control Rate
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Investigators

  • Study Director: Vasileios Askoxylakis, MD, PhD, Merrimack

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-310-01-01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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