A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Study ID
- NCT06157892
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Advanced Breast Cancer
- Advanced Gastric Cancer
- Breast Neoplasms
- Gastroesophageal Junction Adenocarcinoma
- HER2 Low Breast Neoplasms
- HER2 Positive Breast Neoplasms
- Metastatic Breast Cancer
- Metastatic Gastric Cancer
- Stomach Neoplasms
- Triple Negative Breast Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- disitamab vedotin — DRUGGiven into the vein (IV; intravenous)
- tucatinib — DRUG300mg given twice daily by mouth (orally)
Study Details
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
Key Dates
- Start date
- May 20, 2024
- Status verified
- May 2026
- Primary completion
- Jul 28, 2029
- Completion
- Jul 28, 2029
Study Design
- Enrollment
- 172 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose Escalation - Previously treated advanced GC/GEJC or breast cancerdisitamab vedotin + tucatinib
- Experimental: Dose Optimization - HER2-low and HER2+ LA/mBCdisitamab vedotin + tucatinib
- Experimental: Dose Optimization - HER2-low and HER2+ LA/mGC/GEJCdisitamab vedotin + tucatinib
- Experimental: Dose Expansion - HER2-low LA/mBCdisitamab vedotin + tucatinib
- Experimental: Dose Expansion - HER2+ LA/mBCdisitamab vedotin + tucatinib
- Experimental: Dose Expansion - HER2-low LA/mGC/GEJCdisitamab vedotin + tucatinib
- Experimental: Dose Expansion - HER2+ LA/mGC/GEJCdisitamab vedotin + tucatinib
Primary Outcome Measure
Number of participants with dose limiting toxicities (DLTs) in dose escalation phase [ Time Frame: Up to 28 days ]
Central Contacts
- Pfizer CT.gov Call Center1-800-718-1021
Locations (82)
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