← Back to Search

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

Study Summary

This trial tests a drug to see if it works to treat advanced solid tumors with HER2. It also looks at safety and side effects.

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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

Secondary outcome measures

Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment

Duration of Response (DOR) per RECIST v1.1 by investigator assessment

Incidence of antidrug antibodies (ADAs)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Disitamab vedotin monotherapyExperimental Treatment1 Intervention

Disitamab vedotin monotherapy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

74,068 Total Patients Enrolled

Medical MonitorStudy DirectorSeagen Inc.

1,660 Previous Clinical Trials

983,669 Total Patients Enrolled

Xuemei LiStudy DirectorSeagen Inc.

2 Previous Clinical Trials

948 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still spots available in this medical trial?

"Confirmation on clinicaltrials.gov reveals that participant recruitment for this trial is ongoing and the study was originally posted to the website on November 30th 2023, with its most recent update being made September 15th 2023."

Answered by AI

Has the Disitamab vedotin single-drug approach gained regulatory approval?

"The safety profile of Disitamab vedotin monotherapy is assessed a 2 as there are some data points suggesting its relative security, but no evidence has been collected to verify its efficacy."

Answered by AI

How many distinct sites are carrying out this research?

"At this moment, 4 trial sites are operational and actively taking on new participants. Norwich, Canton, El Paso will be the most accessible for many people; however other locations exist if that is more convenient."

Answered by AI

How many individuals have thus far enrolled in this experiment?

"Affirmative, clinicaltrials.gov indicates that this research is actively engaging patients to take part in the experiment. It was initially posted on November 30th 2023 and has since been revised as of September 15th 2023. This trial needs 190 individuals across 4 sites for full enrollment completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

2023. "A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003231.

All > Non Small Cell Lung Cancer > Endometrial Cancer