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New treatment option for Advanced Solid Tumors
Official title Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07360314
What this study is testing
What is M7437?
M7437 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants...
- Non-small cell lung cancer (nonsquamous or squamous)
- Triple-negative breast cancer
- Squamous cell carcinoma of head and neck
- Pancreatic ductal adenocarcinoma
You likely 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...
- 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...
- 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.
See the full eligibility 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...
- 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 may apply
- 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...
- 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.
- Other protocol defined exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Huntersville, North Carolina, United States
- Galveston, Texas, United States
- San Antonio, Texas, United States
- Toronto, Canada
- Vancouver, Canada
- Tokyo, Japan
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Huntersville, North Carolina, United States; Galveston, Texas, United States; San Antonio, Texas, United States; Toronto, Canada; Vancouver, Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.