What this study is
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).
What's being tested
- M7437
Intervention · DRUG
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.
- M7437
Intervention · DRUG
Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.
Study details
- Official title
- A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Advanced Solid Tumors
- Enrolling
- 138 people
- Starts
- 2026-02-13
- Est. completion
- 2029-03-28
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator. For each tumor type, participants have received prior lines of therapy, where locally available:; Non-small cell lung cancer (nonsquamous or squamous); Triple-negative breast cancer; Squamous cell carcinoma of head and neck; Pancreatic ductal adenocarcinoma; Gastric cancer; Epithelial ovarian cancer; Participants with ECOG Performance Status (ECOG) less than and equal to (<=) 1; Participants must have blood, liver, and kidney function within safe levels.
You can't join if
- Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.
- Participants with known brain metastases, except those meeting both of the following criteria:; All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).
- Participants with diarrhea (liquid stool) or ileus Grade more than (>) 1 within 1 week of Cycle1Day1.
- Participants with active chronic inflammatory bowel disease and/or bowel obstruction.
- Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openYale University - Yale University School of Medicine
New Haven, Connecticut, United States
- Contact203-785-6221
- Patricia M LoRusso · Principal investigator
RecruitingCarolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Huntersville, North Carolina, United States
- Contact704-947-6599
- John D Powderly · Principal investigator
RecruitingNEXT Houston
Galveston, Texas, United States
- Jennifer M Segar · Principal investigator
RecruitingNEXT Oncology - PARENT
San Antonio, Texas, United States
- Contact210-595-5670
- Ildefonso Ismael Rodriguez Rivera · Principal investigator
Recruiting
5 sites outside the US
Princess Margaret Cancer Centre
Toronto, Canada
- ContactSpreafico
- Anna Spreafico · Principal investigator
RecruitingBC Cancer - Vancouver - BC Cancer Agency
Vancouver, Canada
- Contact6048776000 ext. 673226
- Anna Tinker · Principal investigator
Not yet recruitingNational Cancer Center Hospital
Tokyo, Japan
- Contact+81335422511
- Noboru Yamamoto · Principal investigator
RecruitingHospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit
Barcelona, Spain
- Elena Garralda Cabanas · Principal investigator
Not yet recruitingNEXT Madrid - Hospital Universitario Quironsalud Madrid
Madrid, Spain
- Contact+34666209969
- Valentina Boni · Principal investigator
Recruiting
Study team
Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID MS743701_0001
Study director
Medical Responsible
EMD Serono Research & Development Institute, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.