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Solid TumorsPhase 1NCT03076372

A Study Evaluating MM-310 in Patients With Solid Tumors

A Phase 1 study testing MM-310 in people with Solid Tumors and Urothelial Carcinoma, run by Merrimack Pharmaceuticals at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MM-310
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
5 sitesUnited States
Study dates
22 Feb 2017to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

Vasileios Askoxylakis, MD, PhD contact

617.441.7492

VAskoxylakis@merrimack.com

5 sites in 1 country

United States5 sites, 5 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55902

    Recruiting

  • University California San Francisco

    San Francisco, California, 94143

    Recruiting

  • Honor Health

    Scottsdale, Arizona, 85259

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
MM-310
Keywords
Cancer, Oncology, Phase I, Gemcitabine, Carboplatin, MM-310, EphA2, Ephrin A2, Solid tumors, urothelial carcinoma, gastric carcinoma, squamous cell carcinoma of the head and neck, ovarian cancer, pancreatic ductal adenocarcinoma, prostate adenocarcinoma, non-small cell lung cancer, small cell lung cancer, triple negative breast cancer, endometrial carcinoma, soft tissue sarcoma
Medical subject headings
Carcinoma, Transitional Cell, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MM-310Drug

    MM-310

Study groups in NCT03076372
Study groupRoleWhat they receive
MM-310 monotherapyExperimentalMM-310 will be administered by IV infusion over 90 minutes on the first day of each 21 day cycle.
Receives: Drug: MM-310

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors.

    Measured: 18 months

Secondary outcomes (6)

  1. Serum levels of analytes that comprise MM-310

    Measured: 18 months

  2. Adverse event profile using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

    Measured: 18 months

  3. Presence of human anti-human antibodies to MM-310

    Measured: 18 months

  4. Objective responses based on RECIST v1.1 or other relevant criteria

    Measured: 18 months

  5. Disease Control Rate

    Measured: 18 months

  6. Progression Free Survival

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2017
  2. Study start22 Feb 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03076372
Sponsor's protocol ID
MM-310-01-01-01
Status last verified
Feb 2018
First submitted
1 Mar 2017
Last updated
27 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31400383

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MM-310 in people with Solid Tumors and Urothelial Carcinoma, run by Merrimack Pharmaceuticals at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vasileios Askoxylakis, MD, PhD (617.441.7492, VAskoxylakis@merrimack.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03076372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.

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