Clinical trialPhase 1Recruiting
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 10 October 2025
- Expected end
- 23 February 2029
- Enrollment
- 77 participants
- Sites
- 5
- Primary outcomes
- Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs); Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs); Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 2 November 2026
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).