NCT07216560 · Mabwell (Shanghai) Bioscience Co., Ltd.
First-in-human Study of 7MW4911 in GI Cancer
What this study is about
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and effectiveness in patients with gastrointestinal cancers.
View original scientific description
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Interventions
DRUG
7MW4911
study drug
Primary outcome measures
Incidence and rates of adverse events
Time frame: Up to approximately 2 years
To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors
MTD, RED, and RP2D
Time frame: Up to approximately 2 years
To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged 18 and above
- 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
Exclusion criteria
- 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.
Where
- Port Saint Lucie, Florida
- Boston, Massachusetts
- Long Island City, New York
- New York, New York
- West Valley City, Utah
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations