M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (NCT07166601)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Yale Cancer Center — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Yale Cancer Center — New Haven, Connecticut
- Icahn School of Medicine at Mount Sinai — New York, New York
- NEXT Oncology — San Antonio, Texas
- Princess Margaret Cancer Centre — Toronto,
- National Cancer Center Hospital — Chūōku,
📞 Contact the Study Coordinator
Phone: (888) 275-7376
Email: eMediUSA@emdserono.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumor
- Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression — Iowa City, Iowa
- A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors — Glendale, California
- QTX3046 in Patients With KRAS G12D Mutations — Grand Rapids, Michigan
- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors — Houston, Texas
- First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer — Fullerton, California
- A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors — San Antonio, Texas
Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.