Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests M7437 in people for the first time. It checks safety, how the body handles the drug, and early signs that it may work. It is for people with certain solid cancers that have high levels of a protein called Ly6E and have grown nearby or spread.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a solid cancer confirmed by a tissue test, with high levels of Ly6E.
- The cancer has grown nearby or spread and cannot be removed by surgery.
- Standard treatments have not worked, are not available, or are not suitable for you.
- Listed cancers include non-small cell lung, triple-negative breast, head and neck squamous cell, pancreatic ductal, stomach, and epithelial ovarian cancer.
- Have received prior treatments for your cancer type, where locally available.
- Be fully active or able to do light work, even if hard physical activity is limited.
- Have blood, liver, and kidney test results within safe limits.
- Other study rules may apply.
Who can't join
- Have had another cancer within the past 3 years. Exceptions include certain skin cancers, early cervical cancer, and cancers judged cured with very low risk of returning.
- Have had a blood-forming stem cell transplant from a donor.
- Have cancer that spread to the brain, unless all spots were treated and stable for at least 4 weeks, with no ongoing symptoms from the brain cancer. Lasting effects of brain treatment are allowed.
- Have more than mild diarrhea or ileus (when the bowel stops moving food) within 1 week before treatment starts.
- Have active, long-term bowel inflammation or a blocked bowel.
- Have had serious bleeding in the stomach or intestines within 3 months before treatment starts.
- Other study rules may apply.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * Other protocol defined inclusion criteria may apply Exclusion Criteria: * 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: 1. All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment. 2. 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. * Other protocol defined exclusion criteria may apply.
Study sites (4)
CT
- Yale University - Yale University School of Medicine · New Haven, CT 06510 · Study contact · 203-785-6221Patricia M LoRusso · Principal investigatorMore trials in New Haven
NC
- Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center · Huntersville, NC 28078 · Study contact · 704-947-6599John D Powderly · Principal investigatorMore trials in Huntersville
TX
- NEXT Houston · Galveston, TX 77001Jennifer M Segar · Principal investigatorMore trials in Galveston
- NEXT Oncology - PARENT · San Antonio, TX 78229 · Study contact · 210-595-5670Ildefonso Ismael Rodriguez Rivera · Principal investigatorMore trials in San Antonio