RecruitingPhase 2NCT06157892

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

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrollment

172 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer Breast Neoplasms Gastroesophageal Junction Adenocarcinoma Stomach Neoplasms Advanced Breast Cancer Triple Negative Breast Neoplasms HER2 Low Breast Neoplasms HER2 Positive Breast Neoplasms Metastatic Gastric Cancer Advanced Gastric Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing disitamab vedotin — an antibody-drug that targets a protein called HER2 on cancer cells — in combination with other anti-cancer drugs across several types of solid tumors, including stomach cancer and breast cancer. The study is in early phases, testing safety and the right dose, and then expanding to specific cancer types. **You may be eligible if...** - You have a confirmed solid tumor cancer (such as stomach, esophageal junction, or breast cancer) - Your cancer is advanced, has spread, or cannot be removed by surgery - Your cancer has progressed on or after standard treatments - Your overall health is good (able to carry out daily activities) - Your cancer can be measured on imaging **You may NOT be eligible if...** - You have not yet tried standard treatments available for your cancer - Your tumor type does not qualify for the specific study cohort - Your overall health or organ function does not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdisitamab vedotin

Given into the vein (IV; intravenous)

DRUGtucatinib

300mg given twice daily by mouth (orally)