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New treatment option for GI Cancers
Official title First-in-human Study of 7MW4911 in GI Cancer
ClinicalTrials.gov ID: NCT07216560
What this study is testing
What is 7MW4911?
7MW4911 is an investigational medicine, being studied as a potential treatment for gi cancers.
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
- This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
- Phase 2: a mid-size study of how well it works
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
- Aged 18 and above
- ECOG 0-1
- Life expectancy ≥ 3 months
- Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
- Disease progression after the most recent treatment regimen
You likely can't join if
- Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
- Active, untreated or symptomatic CNS metastasis
- Effusions that require frequent drainage
- Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic...
- Severe respiratory disease that required hospitalization in the last 28 days.
- Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
See the full eligibility criteria
- Aged 18 and above
- ECOG 0-1
- Life expectancy ≥ 3 months
- Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
- Disease progression after the most recent treatment regimen
- At least one measurable lesion according to RECIST v1.1
- Provision of archival tumor tissue or fresh biopsy.
- Adequte hematologic funciton, liver function and renal function.
- Comply with contraceptive requirements
- Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
- Active, untreated or symptomatic CNS metastasis
- Effusions that require frequent drainage
- Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
- Severe respiratory disease that required hospitalization in the last 28 days.
- Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
- Poorly controlled blood glucose with fasting blood glucose above 10mmol/L
- Recipient of allogeneic stem cell transplant or organ transplant
- Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
- Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
- Prohibited treatment and treatment that requires washout period
- Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy.
- Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.
- Major surgeries within 28 days prior to study drug administration
- Investigational therapy within 28 days prior to study drug administration
- Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.
- Use of strong CYP3A4 inhibitor or inducer
- Known hypersensitivity to 7MW4911 or components of the formulation
- Abuse of narcotic or psychoactive drugs
- Pregnant or breastfeeding women
- Other circumstances or conditions where the investigator judges to be unsuitable for study.
The study team makes the final eligibility decision.
Where it's taking place
- Port Saint Lucie, Florida, United States
- Boston, Massachusetts, United States
- Long Island City, New York, United States
- West Valley City, Utah, United States
- Seattle, Washington, United States
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 Port Saint Lucie, Florida, United States; Boston, Massachusetts, United States; Long Island City, New York, United States; West Valley City, Utah, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.