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

  • STATUS
    Recruiting
  • participants needed
    126
  • sponsor
    ModernaTX, Inc.
Updated on 2 August 2021
Investigator
Chen Mei
Primary Contact
Rabin Medical Center (6.6 mi away) Contact
+13 other location

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.

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 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.

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 visceral lesions may be enrolled into the Dose Confirmation Part to confirm that the dose is also appropriate for this subgroup.

Once the MTD/RDE is identified in the Dose Escalation/Dose Confirmation Parts, participants in Arm B will be enrolled into the Dose-Expansion Part in order to assess the preliminary anti-tumor activity of mRNA-2752 in combination with durvalumab.

Following completion of 6 cycles of mRNA-2752, participants may continue with durvalumab alone until disease progression, unacceptable toxicity, or 24 months of treatment (total), whichever is sooner. If a participant is experiencing clinical benefit and it is in the participant's best interest, in the opinion of the Investigator, dosing of mRNA-2752 may continue beyond Cycle 6 (up to 24 total months of treatment) after approval from the Sponsor.

Details
Condition Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Urothelial Cancer, Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Urothelial Cancer, Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Urothelial Cancer, Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Urothelial Cancer, Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Urothelial Cancer, Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Urothelial Cancer
Treatment durvalumab, mRNA-2752, mRNA-2752 + durvalumab, mRNA-2752 + tremelimumab
Clinical Study IdentifierNCT03739931
SponsorModernaTX, Inc.
Last Modified on2 August 2021

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