San Juan Oncology Associates | Farmington, NM
Status and phase
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About
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 or without tucatinib, is 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.
Full description
This clinical trial is to evaluate disitamab vedotin alone and 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-low LA/mBC subjects. 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 2 expansion cohorts in subjects with HER2 low mGC/GEJC and HER2 + LA/mBC.
Enrollment
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Volunteers
Inclusion criteria
General Inclusion Criteria
Dose Escalation Phase Inclusion Criteria
Cohort A (HER2-Low Breast Cancer) Inclusion Criteria
Histologically or cytologically confirmed diagnosis of breast carcinoma
Locally-advanced, unresectable, or metastatic stage
HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
Prior therapies requirements
No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy
Participants with HR+ tumors must have endocrine therapy refractory disease:
Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy.
Cohort B (HER2+ Breast Cancer) Inclusion Criteria
Histologically or cytologically confirmed diagnosis breast carcinoma
Locally-advanced, unresectable, or metastatic stage
HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
Participants must have:
Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria
Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
Locally-advanced, unresectable, or metastatic stage
HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks
Participants must have received:
Must not have received prior treatment with HER2 directed therapy
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
198 participants in 7 patient groups
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Central trial contact
Seagen Trial Information Support
Data sourced from clinicaltrials.gov
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