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Dose Escalation Study of mRNA 2416 for Intratumoral Injection to Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03323398
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Moderna Therapeutics

Brief Summary:
This clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA 2416 in patients with relapsed/refractory solid tumor malignancies or lymphoma

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Solid Tumor Malignancies or Lymphoma Biological: mRNA-2416 Phase 1

Detailed Description:
This is a first-in-human, Phase 1, open-label, multicenter, dose escalation study designed to determine the safety and tolerability of repeated intratumoral injections of mRNA 2416 in patients with advanced relapsed/refractory solid tumor malignancies or lymphoma. The study will include 2 dosing periods: a Dose Escalation Period followed by an Expansion Period at the MTD/RDE as determined by the Dose Escalation Period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA 2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients With Advanced Malignancies
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mRNA-2416 Biological: mRNA-2416
mRNA-2416 escalating dose levels




Primary Outcome Measures :
  1. Percentage of subjects with dose limiting toxicities (DLTs) [ Time Frame: Days 1-28 ]
  2. Percentage of subjects with adverse events (AEs) [ Time Frame: Baseline through 6 months after the last mRNA-2416 dose ]

Secondary Outcome Measures :
  1. Percentage of subjects with anti-OX40L antibodies [ Time Frame: Pre-dose through 14 days after last mRNA-2416 dose ]
  2. Maximum Observed Serum Concentration (Cmax) of mRNA-2416 [ Time Frame: Pre-dose through 29 days after initial mRNA-2416 dose ]
  3. Area under the serum concentration-time curve (AUC) [ Time Frame: Pre-dose through 29 days after initial mRNA-2416 dose ]
  4. Overall response rate based on RECIST v1.1 or Cheson 2014 criteria (lymphomas) [ Time Frame: Baseline through 6 months after last mRNA-2416 dose ]
  5. Duration of response based on RECIST v1.1 or Cheson 2014 criteria (lymphomas) [ Time Frame: Baseline through 6 months after last mRNA-2416 dose ]
  6. Progression-free survival based on RECIST v1.1 or Cheson 2014 criteria (lymphomas) [ Time Frame: Baseline through 6 months after last mRNA-2416 dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to completing any study-specific procedure
  • Histologically- or cytologically-confirmed advanced/metastatic solid tumor or lymphoma that is refractory to standard therapies, or the patient refuses standard therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Adequate hematological and biological function
  • Female patients of childbearing potential must have a negative serum pregnancy test
  • Male and female patients must agree to use a highly reliable method of birth control.

Exclusion Criteria:

  • Active central nervous system tumors or metastases
  • Treatment with prohibited medications (eg, concurrent anti-cancer therapy including other chemotherapy, radiation (local radiation for palliative care is permitted), hormonal anti-cancer treatment, biologic therapy, or immunotherapy) < 28 days prior to the first day of study treatment
  • Active or prior autoimmune disorder within the past 2 years
  • History of primary immunodeficiency, solid organ transplantation, or tuberculosis
  • Any plan to receive a live attenuated vaccine during study treatment
  • History of human immunodeficiency virus infection (testing is not required)
  • Active/chronic hepatitis B or C
  • Females who are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323398


Contacts
Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com

Locations
United States, Arizona
Mayo Clinic Not yet recruiting
Phoenix, Arizona, United States, 85054
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Moderna Therapeutics

Responsible Party: Moderna Therapeutics
ClinicalTrials.gov Identifier: NCT03323398     History of Changes
Other Study ID Numbers: mRNA-2416-P101
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moderna Therapeutics:
mRNA-2416
OX40 ligand
OX40L

Additional relevant MeSH terms:
Neoplasms