M0324 / Advanced Solid Tumor / Pembrolizumab · Phase 1 Trial

M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record for an ongoing Phase 1 first-in-human study of M0324, a biological agent, tested as monotherapy and in combination with pembrolizumab or mFOLFIRINOX chemotherapy in advanced solid tumors. No results are posted; the study is currently recruiting and is designed to identify a recommended dose and safety profile for future expansion cohorts.

What was studied

Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumor; age from 18 Years. Intervention: Part 1: M0324 Monotherapy; Part 2: M0324 + Pembrolizumab; Part 3: M0324 + mFOLFIRINOX. n = 77. 5 sites: United States, Canada, Japan.

Key findings

Safety

No efficacy data, safety data, or dose recommendations are yet available. Follow-up duration extends to Month 40, but interim or final safety reports are not available in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

First-in-human Phase 1 study with no results posted; designed to establish safety, tolerability, and recommended dose rather than to prove efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) (assessed at Day 1 up to Day 21); Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (assessed at Up to Month 40); Part 3: Number of Participants With Dose Limiting Toxicities (DLTs) (assessed at Day 1 up to Day 35)

DesignPhase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose

PopulationAdvanced Solid Tumor; age from 18 Years

Sample size77

InterventionPart 1: M0324 Monotherapy; Part 2: M0324 + Pembrolizumab; Part 3: M0324 + mFOLFIRINOX

Setting5 sites: United States, Canada, Japan

Reported figures

Quoted from the source exactly as published.

Estimated enrollment77

Study phasePhase 1

Primary outcome (Parts 1 and 2)Number of Participants With Dose Limiting Toxicities (DLTs), Day 1 up to Day 21

Primary outcome (Parts 1, 2, and 3)Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Up to Month 40

Primary outcome (Part 3)Number of Participants With Dose Limiting Toxicities (DLTs), Day 1 up to Day 35

Caveats

This is a registry record with no results posted; study is actively recruiting.
No efficacy data, safety data, or dose recommendations are yet available.
Detailed inclusion and exclusion criteria, study site locations, and actual enrollment are not provided.
Follow-up duration extends to Month 40, but interim or final safety reports are not available in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Prospective Phase 1 interventional trial with dose escalation design.

Directness

limited

First-in-human study; primary endpoints are safety and tolerability, not clinical efficacy.

Consistency

insufficient

No results reported in registry record; consistency cannot be assessed.

Risk of bias

insufficient

Study ongoing and recruiting; methods for blinding and allocation concealment not stated.

Sample adequacy

limited

Estimated 77 participants across three treatment arms; typical for Phase 1 dose escalation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07166601). This is a study registration, not published results. Lead sponsor: EMD Serono Research & Development Institute, Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 77 participants (ESTIMATED). Conditions: Advanced Solid Tumor. Interventions: BIOLOGICAL: M0324; BIOLOGICAL: M0324; BIOLOGICAL: Pembrolizumab; DRUG: mFOLFIRINOX. Primary outcome measures: Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) , Day 1 up to Day 21; Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) , Up to Month 40; Part 3: Number of Participants With Dose Limiting Toxicities (DLTs) , Day 1 up to Day 35. Brief summary: 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

EMD Serono Research & Development InstituteM0324Advanced Solid TumorPembrolizumabNCT07166601mFOLFIRINOX