Advanced Solid Tumors study: M7437
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 intravenous medicine being studied as a potential treatment for advanced solid tumors that express Ly6E.
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 study aims to see if M7437 is safe, how well people tolerate it, how the drug moves through the body, and whether it shows any early signs of working against the cancer.
- Who it's for
- Adults with locally advanced or metastatic solid tumors that have known Ly6E expression, such as certain lung, breast, ovarian, head‑and‑neck, pancreatic, or stomach cancers.
- What's involved
- Participants will receive intravenous infusions of M7437 and will have regular blood draws and imaging scans to monitor safety, drug levels, and any tumor response.
- Time commitment
- The trial runs for several months, with clinic visits for infusions and tests every few weeks.
- 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
- Non-small cell lung cancer (nonsquamous or squamous)
- Triple-negative breast cancer
- Squamous cell carcinoma of head and neck
- Pancreatic ductal adenocarcinoma
- Gastric cancer
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...
- 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.
- Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.
See the full eligibility criteria
- 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...
- 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 is enrolling
- New Haven, Connecticut, United States
- Huntersville, North Carolina, United States
- Galveston, Texas, United States
- San Antonio, Texas, United States
- Toronto, Canada
- Tokyo, Japan
- 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, but 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?
This study is enrolling now at New Haven, Connecticut, United States; Huntersville, North Carolina, United States; Galveston, Texas, United States; San Antonio, Texas, United States; Toronto, Canada; Tokyo, Japan and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.