Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Part of paid clinical trials in San Francisco, California.
- Sponsor
- ModernaTX, Inc.
- Study ID
- NCT03739931
- Phase
- PHASE1
- Status
- Completed
Conditions
- Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma
- Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- mRNA-2752 — BIOLOGICALSolution for intratumoral injection
- Durvalumab — BIOLOGICALSolution for infusion after dilution
Study Details
The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
Key Dates
- Start date
- Nov 27, 2018
- Status verified
- Aug 2025
- Primary completion
- Aug 1, 2025
- Completion
- Aug 1, 2025
Study Design
- Enrollment
- 134 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: mRNA-2752Participants will be administered mRNA-2752 at an applicable dose as monotherapy.
- Experimental: Arm B: mRNA-2752 + DurvalumabParticipants will be administered mRNA-2752 at an applicable dose in combination with durvalumab.
- Experimental: Arm C: mRNA-2752 Alone or mRNA-2752 + DurvalumabParticipants will be administered mRNA-2752 at an applicable dose as monotherapy or in combination with durvalumab.
Primary Outcome Measure
Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | - |
| Providence St. John's Health Center | Santa Monica | California | 90404 | - |
| University of Colorado Denver | Aurora | Colorado | 80045 | - |
| Yale Cancer Center | New Haven | Connecticut | 06510 | - |
| Sarah Cannon Research Institute at Florida Cancer Specialists | Sarasota | Florida | 34232 | - |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | - |
| Cancer Center at Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
| Henry Ford Hospital | Detroit | Michigan | 48202 | - |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | - |
| NYU Langone Medical Center | New York | New York | 10016 | - |
| James P. Wilmot Cancer Center | Rochester | New York | 14642 | - |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | - |
| Oregon Health and Science University | Portland | Oregon | 97239-3011 | - |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | - |
Find similar trials in San Francisco, CA
By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAProvidence St. John's Health Center· Santa Monica, CAUniversity of Colorado Denver· Aurora, COYale Cancer Center· New Haven, CTSarah Cannon Research Institute at Florida Cancer Specialists· Sarasota, FLThe University of Chicago Medicine· Chicago, IL