Disitamab Vedotin for HER2-Positive Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, disitamab vedotin (DV), to determine its effectiveness in treating certain advanced or metastatic cancers with the HER2 marker. Participants will receive DV every two weeks to evaluate its effectiveness and safety in treating head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. Suitable candidates include patients with one of these cancers that have spread or cannot be surgically removed and have experienced disease progression after standard treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not have had prior treatment with an MMAE-containing agent and should not have a known hypersensitivity to any excipient in disitamab vedotin. It's best to discuss your current medications with the trial team.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have progressed after certain treatments, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that disitamab vedotin is likely to be safe for humans?
Research has shown that disitamab vedotin (DV) demonstrates promising safety results in studies for various cancers. For head and neck cancer, one study found DV generally safe, with about 33% of patients with HER2-positive breast cancer responding to the treatment, suggesting it might be well-tolerated in similar cancers.
In non-small cell lung cancer, DV proved safe, with 45.5% of patients responding to the treatment and most maintaining disease control. This indicates the treatment was generally well-tolerated, with manageable side effects.
For ovarian cancer, studies suggest DV is both effective and tolerable in HER2-positive cases. Similarly, in endometrial cancer, DV showed promising results with manageable side effects.
These findings suggest that DV is generally well-tolerated across different cancer types, with side effects that most patients can manage. However, participants should always discuss potential side effects with their doctors to understand how they might be affected individually.12345Why do researchers think this study treatment might be promising?
Disitamab Vedotin is unique because it targets HER2-positive cancers with an innovative approach. Unlike traditional chemotherapy, which broadly attacks fast-growing cells, Disitamab Vedotin is an antibody-drug conjugate. This means it combines a targeted antibody with a chemotherapy drug, allowing it to specifically seek out and destroy cancer cells that overexpress the HER2 protein. Researchers are excited about this treatment because it has the potential to offer a more precise and effective option with potentially fewer side effects for patients with head and neck, non-small cell lung, ovarian, and endometrial cancers.
What evidence suggests that disitamab vedotin might be an effective treatment for HER2-positive cancer?
Research has shown that disitamab vedotin (DV) could effectively treat HER2-positive cancers. In this trial, participants with head and neck cancer will receive DV, and studies found that about 34.4% of patients experienced tumor shrinkage. For those with non-small cell lung cancer, DV has helped control tumor growth. Participants with ovarian cancer will also receive DV, which has proven effective and safe, with studies suggesting it can help manage tumor progression. In endometrial cancer, DV demonstrated strong anti-tumor effects, with some patients experiencing complete tumor disappearance. Overall, DV's ability to target and destroy cancer cells makes it a promising option for those with HER2-positive tumors.12456
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors like head and neck, lung, endometrial, or ovarian cancer that have a HER2 marker. They must have tried platinum-based therapy without success and can't have had too many prior treatments. People with untreated brain metastases, previous HER2-targeted ADC treatment, recent other cancers, or sensitivity to DV ingredients cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive disitamab vedotin (DV) once every 2 weeks to treat solid tumors expressing HER2
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Disitamab Vedotin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seagen Inc.
Lead Sponsor
Dr. Roger Dansey
Seagen Inc.
Chief Medical Officer since 2018
MD from University of Witwatersrand
David R. Epstein
Seagen Inc.
Chief Executive Officer since 2022
BSc in Pharmacy from Rutgers University, MBA from Columbia University
Seagen, a wholly owned subsidiary of Pfizer
Lead Sponsor