7MW4911 for Gastrointestinal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called 7MW4911 to determine its safety and effectiveness for people with advanced gastrointestinal cancer. It targets individuals whose cancer has worsened despite standard treatments. The goal is to gather early data on 7MW4911's effectiveness and safety profile. Suitable participants are those whose cancer has progressed after their last treatment and who have at least one measurable cancerous lesion. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires stopping certain medications, like strong CYP3A4 inhibitors or inducers, and any cancer therapy within 21 days before starting the study drug. If you're on immunosuppressive agents, you need to stop them 28 days before starting the trial.
Is there any evidence suggesting that 7MW4911 is likely to be safe for humans?
Research has shown that 7MW4911 has a strong safety record in early lab and animal studies. In mice, the drug did not spread much throughout the body, indicating good safety. It moved through the body predictably, without accumulating to harmful levels, and exited the system at a moderate pace.
The treatment also proved safe in various tests for gastrointestinal cancer, as it did not cause severe side effects. While these results are promising, this trial marks the first time 7MW4911 is being tested in humans. Therefore, the researchers have carefully designed the trial to ensure safety for participants.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for gastrointestinal cancer, which typically include chemotherapy, radiation, and surgery, 7MW4911 offers a fresh approach. Researchers are excited about 7MW4911 because it has a novel mechanism of action, potentially targeting cancer cells in a way that existing therapies do not. This could mean that 7MW4911 might be more effective or have fewer side effects than current options. If successful, it could change how we treat gastrointestinal cancer, providing a new option that works differently from what is currently available.
What evidence suggests that 7MW4911 might be an effective treatment for gastrointestinal cancer?
Studies have shown that 7MW4911, the investigational treatment tested in this trial, is a promising new option for gastrointestinal cancers. It targets a protein called cadherin 17, found in these cancers, using a special approach that combines an antibody with a cancer-fighting drug. This method delivers the drug directly to the tumor. Research indicates that 7MW4911 demonstrated strong anti-tumor effects in early tests, leading to significant tumor shrinkage. It proved effective in various types of gastrointestinal cancers, even those usually resistant to many drugs. These findings suggest that 7MW4911 could offer a new and effective treatment for patients with these cancers.12345
Are You a Good Fit for This Trial?
Adults over 18 with advanced or metastatic gastrointestinal cancer that worsened after standard treatment can join this trial. They should be relatively healthy (ECOG 0-1), expected to live at least 3 months, have a measurable tumor, and provide tissue samples. Good blood, liver, and kidney function are needed, along with following birth control rules.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 7MW4911 to evaluate safety, pharmacokinetics, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 7MW4911
Trial Overview
The study is testing the safety and effectiveness of a new drug called 7MW4911 for patients in the US with gastrointestinal cancers. It's the first time humans will receive this drug.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mabwell (Shanghai) Bioscience Co., Ltd.
Lead Sponsor
Citations
1.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_1/5466/760197/Abstract-5466-7MW4911-a-novel-cadherin-17Abstract 5466: 7MW4911, a novel cadherin 17-targeting ADC ...
Abstract 5466: 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers Free.
Overcoming multidrug resistance in gastrointestinal ...
Preliminary results demonstrated that 7MW4911 exhibited anti-tumor activity across all CMS subtypes, irrespective of the subtype-specific CDH17 ...
First-in-human Study of 7MW4911 in GI Cancer
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal ...
Mabwell's CDH17-targeting ADC 7MW4911 Receives IND ...
The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal ...
5.
targetedonc.com
targetedonc.com/view/fda-clears-phase-1-2-study-for-novel-cdh17-targeting-adc-in-advanced-gi-cancersFDA Clears Phase 1/2 Study for Novel CDH17-Targeting ...
In preclinical models, 7MW4911 demonstrated broad antitumor efficacy, showing significant tumor regression across a variety of patient-derived ...
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