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

PHASE1RecruitingINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

October 10, 2025

Primary Completion Date

February 23, 2029

Study Completion Date

February 23, 2029

Conditions
Advanced Solid Tumor
Interventions
BIOLOGICAL

M0324

M0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE).

BIOLOGICAL

M0324

M0324 will be further investigated in part 2 and part 3 of the study as combination regimen, in order to determine dose-toxicity relationship in combination and MTD (if reached) in order to support selection of RDE(s) in combination.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered intravenously as per standard of care.

DRUG

mFOLFIRINOX

mFOLFIRINOX will be administered intravenously as per standard of care.

Trial Locations (5)

10029

NOT_YET_RECRUITING

Icahn School of Medicine at Mount Sinai, New York

78249

RECRUITING

NEXT Oncology, San Antonio

06510

NOT_YET_RECRUITING

Yale University School of Medicine, New Haven

Unknown

NOT_YET_RECRUITING

Princess Margaret Cancer Centre, Toronto

NOT_YET_RECRUITING

National Cancer Center Hospital, Chūōku

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT07166601 - M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors | Biotech Hunter | Biotech Hunter