Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Adil Daud (ucsf)
Headshot of Adil Daud
Adil Daud

Description

Summary

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.

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

Details

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 participants with histologically confirmed advanced or metastatic solid tumor malignancies or lymphoma. The study consists of Dose Escalation and Dose Confirmation Parts, which will occur in Arm A and Arm B, followed by a Dose Expansion Part, which will occur in Arm B, and a Dose Exploration in Arm C as a neoadjuvant therapy for cutaneous melanoma.

Participants in Arm A and in Arm B will be enrolled into the Dose Escalation Part and the doses of mRNA-2752 will be administered in a dose escalation regimen until a maximum tolerated dose (MTD) or a recommended dose for expansion (RDE) is identified. When the MTD/RDE is identified, participants with solid tumors or lymphoma with visceral lesions may be enrolled into the Dose Confirmation Part to confirm that the dose is also appropriate for this subgroup.

Keywords

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, mRNA-2752, OX40L, IL-23, IL-36γ, Intratumoral injection, Lymphoma, Neoplasms, Triple Negative Breast Neoplasms, Durvalumab, mRNA-2752 + Durvalumab

Eligibility

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94143 United States
  • Providence St. John's Health Center
    Santa Monica California 90404 United States

Lead Scientist at University of California Health

  • Adil Daud (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 208 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ModernaTX, Inc.
ID
NCT03739931
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 134 people participating
Last Updated