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NCT06003231 · ClinicalTrials.gov registry record · Phase 2
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
A Phase 2 study of Carcinoma, Non-Small Cell Lung and Ovarian Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06003231: Active Phase 2 study of Carcinoma, Non-Small Cell Lung and Ovarian Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT06003231 is a Phase 2 study of Carcinoma, Non-Small Cell Lung and Ovarian Neoplasms that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 120 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06003231, a Phase 2 study of Carcinoma, Non-Small Cell Lung and Ovarian Neoplasms, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks. This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Primary Outcome
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Conditions Studied
Interventions
- DRUG disitamab vedotin
Study Locations (20)
Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Chandler
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Gilbert
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Glendale
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Mesa
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Mesa
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Phoenix
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Scottsdale
California
- Valkyrie Clinical Trials(Additional Suite) - Los Angeles
- Valkyrie Clinical Trials - Los Angeles
- University of California Davis Comprehenvise Cancer Center - Sacramento
- University of California Davis Medical Center - Sacramento
- Providence Medical Foundation - Santa Rosa
Connecticut
- Smilow Cancer Hospital at Yale - New Haven - New Haven
- Yale-New Haven Hospital-Yale Cancer Center - New Haven
- Smilow Cancer Hospital Phase 1 Unit - New Haven
- Yale Cancer Center - New Haven
- Smilow Cancer Hospital Care Center at Trumbull - Trumbull
Florida
- Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center - Coral Gables
- University of Miami Hospital and Clinics Deerfield Beach - Deerfield Beach
Colorado
- PCM Trials - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
What the registry record for NCT06003231 still lists
NCT06003231 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (63% lower).
The record links to 4 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 1 intervention - of which disitamab vedotin is the first listed.
NCT06003231 names 20 study sites across 5 states, led by Arizona, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06003231 about?
NCT06003231 is a clinical study titled "A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2". This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endom...
What is the current status of trial NCT06003231?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-11-14. Estimated completion is 2028-05-31.
What conditions does trial NCT06003231 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Ovarian Neoplasms, Head and Neck Neoplasms, Endometrial Neoplasms.
What interventions are being tested in trial NCT06003231?
The interventions under investigation include: disitamab vedotin (DRUG).
Who is sponsoring clinical trial NCT06003231?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06003231 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06003231's enrollment target sits among peer trials
120 67th of 130 higher than 63 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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