Phase 1 Trial of mRNA-4106 Begins Dosing Patients With Solid Tumors
A phase 1 trial of mRNA-4106 has dosed its first patient with an advanced or metastatic solid tumor.
Tumor cell: ©nevio - stock.adobe.com
The first patient has been dosed with mRNA-4106, a novel pantumor antigen therapy candidate, in a phase 1 trial (NCT06880549) for those with advanced or metastatic solid tumors.1
In the open-label, multicenter, dose-escalation study, investigators plan to assess mRNA-4106’s safety, pharmacodynamics, immunogenicity, and preliminary efficacy when given both alone and in combination with checkpoint inhibitor therapy to patients with solid tumors.2
In arm 1 of the trial, the dose-escalation portion, patients will receive mRNA-4106 at a test dose as monotherapy. In arm 2, the dose-confirmation portion, patients will be treated with mRNA-4106 at an applicable dose in combination with nivolumab/relatlimab (Opdualag) at a standard dose.
"mRNA represents a bold new frontier in cancer immunotherapy, and we're proud to provide our patients access to this innovative treatment as part of a first-in-human trial. At START, our mission is to ensure that scientific breakthroughs translate into real-world options for patients—this study is a powerful example of that commitment," said Amita Patnaik, MD, FRCPC, medical oncologist and co-founder of START in San Antonio, Texas, in a press release.1
The study has an estimated enrollment of 57 patients.2 Patients are currently being recruited at sites in Michigan, Texas, and Utah.
In arm 1, where patients will receive mRNA-4106 alone, patients are required to have histologically confirmed advanced or metastatic cancer, including melanoma, non–small cell lung cancer; urinary bladder cancer; colon/rectal adenocarcinomas; or gastric, ovarian, cervical, endometrial, hepatocellular, esophageal, and head and neck squamous cell carcinomas. Patients are required to have measurable disease as determined by RECIST v1.1, have completed or refused all standard therapies, have a tumor lesion amenable to biopsy, or archival tumor tissue that was collected within 1 year of the enrollment date.
In arm 2, patients must have histologically confirmed unresectable or metastatic melanoma, with measurable disease as determined by RECIST v1.1. Patients must not have received any previous therapy for this cancer in the first line. Additionally, prior adjuvant, neoadjuvant, or perioperative melanoma therapy is permitted if disease recurrence did not occur within 3 months from the patient's last treatment date.
Additional enrollment criteria require patients to have an ECOG performance status of 0 or 1 and adequate hematological and biological function. For patients who could become pregnant, a negative pregnancy test is required within 24 hours before the first dose of study treatment.
The primary end points of the trial are to determine the number of patients with dose-limiting toxicities, treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest.
"With mRNA-4106, we sought to design an inclusive therapy that encodes for antigens commonly shared across patients and tumor types. We are thrilled to be able to bring this medicine to trial participants, and in partnership with forward-thinking site networks like START, further showcase the promise of mRNA to transform cancer care," said Rose Loughlin, PhD, executive vice president of research at Moderna, in the press release.1
