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Monoclonal Antibodies
Disitamab Vedotin for HER2-Positive Cancer
Phase 2
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called disitamab vedotin (DV) on patients with advanced or metastatic cancers that have a specific marker called HER2. The drug works by finding and attaching to cancer cells, then delivering a substance to kill them. The study aims to see if DV is effective and safe for these patients. Disitamab vedotin is an antibody-drug conjugate designed for targeting HER2 that has been approved for urothelial carcinoma and gastric cancer.
Who is the study for?
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.
What is being tested?
The study tests disitamab vedotin (DV), an experimental antibody-drug conjugate designed to target and kill cancer cells in tumors expressing the HER2 marker. Participants will receive DV every two weeks to evaluate its effectiveness against various solid tumors and assess its safety profile.
What are the potential side effects?
Potential side effects of DV include reactions at the infusion site, possible damage to healthy cells leading to fatigue, nausea or hair loss among others. The trial aims to document all adverse effects experienced by participants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Secondary study objectives
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Number of participants with adverse events (AEs)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Disitamab vedotin monotherapyExperimental Treatment1 Intervention
Disitamab vedotin monotherapy
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian tumors include antibody-drug conjugates (ADCs) like Disitamab Vedotin, which target specific markers such as HER2 on cancer cells and deliver cytotoxic agents directly to them. This targeted approach helps minimize damage to healthy tissues.
Other treatments include chemotherapy, which kills rapidly dividing cells, and targeted therapies like PARP inhibitors and angiogenesis inhibitors, which disrupt cancer cell DNA repair and blood vessel formation, respectively. Understanding these mechanisms is crucial for selecting the most effective treatment, improving outcomes, and reducing side effects for ovarian tumor patients.
Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.
Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.
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Who is running the clinical trial?
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,178 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,677 Previous Clinical Trials
989,136 Total Patients Enrolled
Xuemei LiStudy DirectorSeagen Inc.
2 Previous Clinical Trials
948 Total Patients Enrolled
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