The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
138
Participants will receive M7437 as an intravenous infusion at a dose corresponding to their assigned cohort. Dose escalation will occur between cohorts, with 3-4 participants enrolled at each dose level before proceeding to the next higher dose.
Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.
Yale University - Yale University School of Medicine
New Haven, Connecticut, United States
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Huntersville, North Carolina, United States
NEXT Houston
Galveston, Texas, United States
NEXT Oncology - PARENT
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
Time frame: DLT period is 21 days (cycle 1)
Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
Time frame: Up to end of Part 1 of study (approximately 1 year 8 months)
Dose-escalation Cohort: Plasma Concentration of M7437
Time frame: Cycle 1 Day 1: Pre-dose, 0.25, 6, 24, 96, 168 and 336 hours post-dose; Cycle 3 Day 1: Pre-dose, 0.25, 6 and 168 hours post-dose; Pre-dose at Day 1 of Cycles 2, 4, 6, 8 until end of treatment (approximately 1 year 8 months) (Each Cycle length=21 days)
Dose-escalation Cohort: Overall Response (OR) According to Response Evaluation Criteria inSolid Tumor (RECIST) version 1.1 criteria as Assessed by Investigator
Time frame: From the date of first documented complete response (CR) or partial response (PR), whichever occurs first, until the first documented disease recurrence or progressive disease (PD) (assessed upto [approximately 1 year 8 months])
Change From The Baseline Qtc (Δqtc) At Predefined Timepoints Based on Triplicate Electrocardiogram (ECG) Measurements
Time frame: Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 5, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1 (each cycle is of 21 days)
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San Antonio, Texas, United States
Princess Margaret Cancer Centre
Toronto, Canada
BC Cancer - Vancouver - BC Cancer Agency
Vancouver, Canada
National Cancer Center Hospital
Tokyo, Japan
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Madrid, Spain