Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by EMD Serono Research & Development Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2025-10-10 |
| Est. Completion | 2029-02-23 |
| Phase | Phase 1 |
What NCT07166601 shows while recruiting
NCT07166601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (60% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07166601's enrollment target sits among peer trials
77 140th of 189 higher than 50 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
PM14 Administered Intravenously to Patients with Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
RECRUITING · Phase 1
-
Study of AVZO-021 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02127398 · 77 participants · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
- NCT04159103 · 77 participants · Phase 1
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
- NCT04683003 · 77 participants · Phase 3
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT05004116 · 77 participants · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI