This clinical trial is looking at solid tumor cancers, such as breast and gastric cancer. It focuses on tumors with a protein called HER2 that can make the cancer grow faster. The study aims to see how safe and effective a new drug, disitamab vedotin, is when combined with an existing drug called tucatinib. These treatments are meant for patients whose cancer has progressed despite previous therapies.
The trial's ID is NCT06157892. It is in Phase 2, which means it is looking at how well the treatments work and how safe they are. The trial is regulated by the FDA and aims to include about 172 participants.
Who can join
Adults aged 18 and older can join this study. It is open to both men and women with certain types of breast or gastric cancer that are advanced or have spread. Participants must have tumors that test positive for HER2. The trial team will check to make sure each person meets the eligibility criteria.
Conditions
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms, Stomach Neoplasms, Triple Negative Breast Neoplasms, Metastatic Breast Cancer, Metastatic Gastric Cancer, Advanced Breast Cancer, Advanced Gastric Cancer
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will receive either disitamab vedotin and tucatinib together. The study has different groups based on the type of HER2 status of the cancer. Some participants will be in a dose escalation phase to find the right amount of drugs, while others will be in an optimization phase to test the best dose. Everyone gets the treatment, but the specifics depend on their cancer type.
Where
This trial is running at 141 locations.
Banner-University Medical Center Tucson Campus
Tucson, Arizona
Recruiting
Banner-University Medical Center Tucson Campus
Tucson, Arizona
Recruiting
The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
Tucson, Arizona
Recruiting
University of Arizona Cancer Center - North Campus
Tucson, Arizona
Recruiting
The University of Arizona Cancer Center-Main
Tucson, Arizona
Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California
Recruiting
UC Irvine Medical Center
Orange, California
Recruiting
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California
Recruiting
The first 8 of 141 sites are listed here. The registry record has the full list.