M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Registration Number
- NCT07166601
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 77
Part 1- M0324 Monotherapy:
• Participants with certain advanced/metastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
Part 2- M0324 Combination with Pembrolizumab:
• Participants with certain advanced/metastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.
Part 3- M0324 Combination with mFOLFIRINOX:
- Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and/or adjuvant chemotherapy are not permitted
- Other protocol defined inclusion criteria could apply
- Has a history of chronic diarrhea greater than or equal to (>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
- Participant has a history of malignancy within 3 years before the date of enrollment
- Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure [New York Heart Association (NYHA) >= II] or a coronary revascularization procedure within 180 days of study entry
- Life expectancy of less than 3 months
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: M0324 Monotherapy M0324 - Part 2: M0324 + Pembrolizumab Pembrolizumab - Part 3: M0324 + mFOLFIRINOX M0324 - Part 2: M0324 + Pembrolizumab M0324 - Part 3: M0324 + mFOLFIRINOX mFOLFIRINOX -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324 From Day 1 up to approximately 40 months Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324 From Day 1 up to approximately 40 months Percent Change from Baseline in Pharmacodynamic Markers From Day 1 up to approximately 40 months Pharmacodynamic and circulating biomarkers (e.g. cytokines) will be measured in blood.
Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Time from first study treatment until first documentation of progressive disease (PD) or death, assessed approximately up to 40 months Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator Time from first documentation of OR until progressive disease (PD) or death, assessed approximately up to 40 months Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator Time from first study treatment until progressive disease or death up to approximately 40 months Part 3: Overall Survival (OS) Time from first study treatment until death, assessed approximately up to 40 months Number of Participants With Positive Anti-Drug Antibody (ADA) of M0324 Up to Month 40
Trial Locations
- Locations (5)
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Canada
National Cancer Center Hospital
🇯🇵Chūōku, Japan
Yale University School of Medicine🇺🇸New Haven, Connecticut, United States