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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03739931
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Moderna Therapeutics

Brief Summary:
The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA 2752 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-2752 Biological: mRNA-2752 + durvalumab Biological: mRNA-2752 + tremelimumab Phase 1

Detailed Description:
This is a Phase 1, open-label, multicenter, dose escalation study of intratumoral injections of mRNA-2752 alone and in combination with intravenously administered immune checkpoint blockade therapy in patients with histologically confirmed advanced or metastatic solid tumor malignancies or lymphoma. The study consists of 3 dose escalation and dose confirmation parts (Arms A, B, and C) followed by Dose Expansion parts in select indications.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36γ, for Intratumoral Injection Alone and in Combination With Immune Checkpoint Blockade
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: mRNA-2752 Biological: mRNA-2752
mRNA-2752 dose escalation and expansion

Experimental: Arm B: mRNA-2752 + duvalumab Biological: mRNA-2752 + durvalumab
mRNA-2752 + durvalumab dose escalation and expansion

Experimental: Arm C: mRNA-2752 + tremelimumab Biological: mRNA-2752 + tremelimumab
mRNA-2752 + tremelimumab dose escalation and expansion




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 3 months after the last dose of study treatment ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Baseline through 180 days after the last dose of study treatment ]
    Percentage of patients with tumor response (partial or complete)

  2. Protein expression of IL-23, IL-36γ and OX40L in tumors [ Time Frame: Baseline through 58 days after initial mRNA-2752 dose ]
  3. Concentrations of mRNA-2752 in blood and non-compartmental PK parameters [ Time Frame: Pre-dose through 29 days after initial mRNA-2752 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 confirmed advanced or metastatic disease with at least 1 measurable lesion as determined by RECIST v1.1 or Cheson 2016 criteria; and who has disease progression after adequate standard of care therapies for metastatic disease that are known to confer clinical benefit, is intolerant to treatment, or refuses standard treatment (no limit to prior lines of therapy).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate hematological and biological function
  • Has evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Exclusion Criteria:

  • Has received prior systemic anti-cancer therapy including investigational agents within 28 days of the start of study treatment.
  • Has current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment.
  • Active central nervous system tumors or metastases
  • Active or prior documented autoimmune or inflammatory disorders
  • History of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
  • Is a female patient who is pregnant or breastfeeding or male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 120 days after the last dose of study treatment.

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): NCT03739931


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

Locations
United States, Florida
Sarah Cannon Research Institute at Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact    941-377-9993      
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-329-7440      
Sponsors and Collaborators
Moderna Therapeutics
AstraZeneca

Responsible Party: Moderna Therapeutics
ClinicalTrials.gov Identifier: NCT03739931     History of Changes
Other Study ID Numbers: mRNA-2752-P101
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 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-2752
OX40L
IL-23
IL-36γ
Intratumoral injection

Additional relevant MeSH terms:
Neoplasms
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs