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A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors


Active: Yes
Cancer Type: Breast Cancer
Stomach/ Gastric Cancer
NCT ID: NCT06157892
Trial Phases: Phase II Protocol IDs: SGNDV-004 (primary)
NCI-2024-01557
2023-507555-29-00
C5731004
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Seagen, a wholly owned subsidiary of Pfizer
NCI Full Details: http://clinicaltrials.gov/show/NCT06157892

Summary

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.

Objectives

This clinical trial is to evaluate disitamab vedotin in combination with tucatinib in
subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The
study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by
a dose optimization phase. The 2 dose levels identified in the dose escalation phase will
be assessed in the optimization phase for both safety and efficacy in HER2-expressing
LA/mBC and LA/mGC/GEJC. Once the safety and efficacy profile of disitamab vedotin plus
tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk
ratio has been determined the disitamab vedotin plus tucatinib combination therapy will
be evaluated in an expansion phase with 4 expansion cohorts in subjects with HER2-low
LA/mGC/GEJC, HER2+ LA/mGC/GEJC, HER2-low LA/mBC, and HER2+ LA/mBC.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.