ClinicaliQ Trial Snapshot
- Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors — Recruiting • Phase I • Oncology • NCT05533697.
- What is being tested: mRNA-4359, a novel immunotherapy agent, is being evaluated for safety and tolerability when administered as monotherapy and in combination with established immune checkpoint inhibitors (pembrolizumab or the ipilimumab-nivolumab combination) in patients with advanced solid tumours.
- Patient eligibility overview: The trial enrolls adults with advanced solid tumours; specific eligibility criteria typically include confirmed malignancy, adequate organ function, and prior treatment history depending on the study arm, though detailed criteria would be specified in the full protocol.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.
Eligibility Snapshot
- Key Inclusion Criteria: * Males or females ≥18 years of age who have provided written informed consent prior to completing any study-specific procedure. For Arm 2d, participants ≥12 years are eligible with informed consent/assent. * Dose Escalation (Arm 1a): Participant has histologically confirmed locally advanced or metastatic cancer (cutaneous melanoma, NSCLC, non-muscle invasive bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer [MSS CRC], basal cell carcinoma, or triple negative breast cancer) with measurable disease as determined by RECIST v1.1. Arm 1a participants must have received, and then progressed, relapsed, or been intolerant to, or ineligible for, at least 1 standard treatment regimen in the advanced or metastatic setting. Participants with a known driver mutation must have also received or been offered a mutation-directed therapy, where indicated. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response. * Dose Confirmation (Arm 1b): Participant has histologically confirmed locally advanced or metastatic, and CPI refractory melanoma or locally advanced or metastatic, and CPI refractory NSCLC with measurable disease as determined by RECIST v1.1 who has disease progression after, at least 1 line of standard therapy (no limit to prior…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.