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NCT07166601 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by EMD Serono Research & Development Institute.

Recruiting
Registry status
Phase 1
Development phase
77
Enrollment target
5
Study locations

NCT07166601 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by EMD Serono Research & Development Institute. The registered enrollment target is 77 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (60% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT07166601, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by EMD Serono Research & Development Institute.

RECRUITING
Registry status
Phase 1
Development phase
77 participants
Enrollment target
5
Study locations

Study 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).

Conditions Studied

Advanced Solid Tumor

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG mFOLFIRINOX
  • BIOLOGICAL M0324

Study Locations (5)

Other

  • Princess Margaret Cancer Centre - Toronto
  • National Cancer Center Hospital - Chūōku

Connecticut

  • Yale University School of Medicine - New Haven

New York

  • Icahn School of Medicine at Mount Sinai - New York

Texas

  • NEXT Oncology - San Antonio

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2025-10-10
Est. Completion 2029-02-23
Phase Phase 1

Sponsor

EMD Serono Research & Development Institute

81 total trials

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What the Registry Record Tells You About NCT07166601

The ClinicalTrials.gov registry entry for NCT07166601 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (60% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT07166601 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Other, Connecticut, New York.

Frequently Asked Questions

What is clinical trial NCT07166601 about?

NCT07166601 is a clinical study titled "M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors". 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 (P...

What is the current status of trial NCT07166601?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2025-10-10. Estimated completion is 2029-02-23.

What conditions does trial NCT07166601 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT07166601?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), mFOLFIRINOX (DRUG), M0324 (BIOLOGICAL).

Who is sponsoring clinical trial NCT07166601?

This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07166601 being conducted?

This trial has 5 study locations across Connecticut, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.