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Also known as Intralesional mRNA 2752
mRNA-2752 · 2 trials · 3 indications
To determine the maximum tolerated dose (MTD), and recommended dose for subsequent expansion cohort, of intralesionally administered pembrolizumab in patients with ductal carcinoma in situ (DCIS) of the breast.
To define the dose-limiting toxicities (DLTs), tolerability, and feasibility of intralesional administration of pembrolizumab in patients with DCIS.
To determine the response rate to intralesional pembrolizumab in patients with DCIS, as measured by an increase (baseline vs. post treatment) in intralesional CD8+ T cells, compared to untreated controls.
| Arm | Type | Description |
|---|---|---|
| Arm A: mRNA-2752 | EXPERIMENTAL | Participants will be administered mRNA-2752 at an applicable dose as monotherapy. |
| Arm B: mRNA-2752 + Durvalumab | EXPERIMENTAL | Participants will be administered mRNA-2752 at an applicable dose in combination with durvalumab. |
| Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab | EXPERIMENTAL | Participants will be administered mRNA-2752 at an applicable dose as monotherapy or in combination with durvalumab. |
| CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase) | EXPERIMENTAL | Participants, upon diagnosis with high risk DCIS, will be offered 2 doses of pembrolizumab injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 2nd dose. The participant will then undergo the surgical treatment as determined by the surgeon and the participant (partial mastectomy or mastectomy). |
| CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase) | EXPERIMENTAL | Participants, upon diagnosis with high risk DCIS, will be offered 4 doses of pembrolizumab injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 4th dose. The participant will then undergo the surgical treatment as determined by the surgeon and the participant (partial mastectomy or mastectomy). |
| CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase) | EXPERIMENTAL | Participants, upon diagnosis with high risk DCIS, will be offered 2 doses of pembrolizumab and intralesional mRNA 2752 injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 2nd dose. The participant will then undergo the surgical treatment as determined by the surgeon and the participant (partial mastectomy or mastectomy). |
| mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort) | EXPERIMENTAL | Participants will be offered up to 4 doses of mRNA-2752 injected intralesionally (IL) 3 weeks apart (+/- 1) week) with surgery or core biopsy 3 weeks (+/-1 week). The participants will proceed to biopsy, either image guided or excisional or partial mastectomy |
| mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort) | EXPERIMENTAL | Participants will be will be offered injections of mRNA-2752 given on up to 4 occasions, 3 weeks apart (+/- 1 week) or a combination mRNA-2752 and immune checkpoint inhibitor will be given up to 4 occasions, 3 weeks apart (+/- 1 week). The participants will proceed to biopsy, either image guided or excisional or partial mastectomy. |
| No active treatment | NO_INTERVENTION | The control group will proceed to surgery alone within a 4 month timeframe following the diagnosis of high risk DCIS. |
| Name | Type | Description |
|---|---|---|
| mRNA-2752 | BIOLOGICAL | Solution for intratumoral injection |
| Durvalumab | BIOLOGICAL | Solution for infusion after dilution |
| Pembrolizumab | DRUG | Injected intralesionally |
| Intralesional mRNA 2752 | BIOLOGICAL | Injected intralesionally |
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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Cheson 2016 criteria * Do...
mRNA-2752 is an investigational RNA therapy developed by Moderna, Inc. for intratumoral injection in advanced malignancies. It is being studied in dose escalation for relapsed or refractory solid tumor malignancies or lymphoma, and in dose expansion for triple negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, urothelial cancer, immune checkpoint refractory melanoma, and non-small cell lung cancer.
mRNA-2752 targets OX40L, a protein. It is an intratumoral RNA therapy designed to express this target within the tumor environment. OX40L is the molecular target identified for the program, and the agent is classified as a protein-targeting RNA therapy in Moderna's oncology pipeline.
mRNA-2752 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the agent in advanced malignancies, including the dose escalation and dose expansion study in solid tumors and lymphoma.
mRNA-2752 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes a completed Phase 1 dose escalation study and an early Phase 1 study in high-risk ductal carcinoma in situ that is active but not recruiting.
mRNA-2752 has been studied in NCT03739931, a completed Phase 1 dose escalation and expansion trial of intratumoral injection in advanced malignancies with 134 participants across the United States, Australia, and Israel. It is also in NCT02872025, an active early Phase 1 immunotherapy study in high-risk ductal carcinoma in situ with 42 female participants in the United States.
Yes, intralesional mRNA 2752 is another name for mRNA-2752. Both refer to the same investigational Moderna RNA therapy given by intratumoral or intralesional injection. The name reflects the intralesional route of administration used in the clinical program for advanced malignancies.