A Study Evaluating MM-310 in Patients With Solid Tumors
A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors
1 other identifier
interventional
34
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2017
5 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
February 22, 2017
CompletedFirst Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 27, 2018
February 1, 2018
1.3 years
March 1, 2017
February 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors.
18 months
Secondary Outcomes (6)
Serum levels of analytes that comprise MM-310
18 months
Adverse event profile using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
18 months
Presence of human anti-human antibodies to MM-310
18 months
Objective responses based on RECIST v1.1 or other relevant criteria
18 months
Disease Control Rate
18 months
- +1 more secondary outcomes
Study Arms (1)
MM-310 monotherapy
EXPERIMENTALMM-310 will be administered by IV infusion over 90 minutes on the first day of each 21 day cycle.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +13 more criteria
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Honor Health
Scottsdale, Arizona, 85259, United States
University California San Francisco
San Francisco, California, 94143, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Duke University
Durham, North Carolina, 27710, United States
Related Publications (1)
Huang ZR, Tipparaju SK, Kirpotin DB, Pien C, Kornaga T, Noble CO, Koshkaryev A, Tran J, Kamoun WS, Drummond DC. Formulation optimization of an ephrin A2 targeted immunoliposome encapsulating reversibly modified taxane prodrugs. J Control Release. 2019 Sep 28;310:47-57. doi: 10.1016/j.jconrel.2019.08.006. Epub 2019 Aug 7.
PMID: 31400383DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vasileios Askoxylakis, MD, PhD
Merrimack
Central Study Contacts
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
March 1, 2017
First Posted
March 10, 2017
Study Start
February 22, 2017
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
February 27, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share