OncoMatch/Clinical Trials/NCT06157892
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Is NCT06157892 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including disitamab vedotin and tucatinib for breast neoplasms.
Treatment: disitamab vedotin · tucatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Gastric Cancer
Esophageal Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) low expression (IHC 1+ or IHC 2+/ISH-negative) (IHC 1+ or IHC 2+/ISH-negative)
HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+/ISH+) (IHC 3+ or IHC 2+/ISH+)
HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
Allowed: BRCA1 mutation
Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
Allowed: BRCA2 mutation
Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
Allowed: ESR1 expression (hormone receptor positive)
Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease
Allowed: PR (PGR) expression (hormone receptor positive)
Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease
Allowed: PD-L1 (CD274) overexpression (CPS 10 or greater)
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic cytotoxic chemotherapy — locally advanced/metastatic
Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
Must have received: PARP inhibitor — locally advanced/metastatic
Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
Must have received: topoisomerase I inhibitor (T-DXd, sacituzumab govitecan) — locally advanced/metastatic
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
Must have received: CDK4/6 inhibitor — adjuvant or metastatic
had received a CDK4/6 inhibitor in the adjuvant or metastatic setting
Must have received: endocrine therapy — locally advanced/metastatic
Progressed on 2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
Must have received: anti-PD-1 therapy (pembrolizumab) — locally advanced/metastatic
Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab (or other PD-(L)1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab) — advanced
Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
Must have received: taxane — advanced
Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
Must have received: HER2-targeted therapy (trastuzumab) — locally advanced/metastatic
Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
Must have received: fluoropyrimidine — locally advanced/metastatic
Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
Must have received: platinum-based chemotherapy — locally advanced/metastatic
Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
Must have received: systemic cytotoxic chemotherapy (platinum, fluorouracil, taxane) — locally advanced/metastatic
Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
Cannot have received: antibody-drug conjugate with MMAE payload
Prior therapy with ADCs with MMAE payload
Cannot have received: HER2-targeted therapy
Must not have received prior treatment with HER2 directed therapy
Cannot have received: tucatinib (tucatinib)
Prior therapy with tucatinib
Cannot have received: systemic anticancer treatment
Exception: within 4 weeks prior to first dose of study treatment
Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner-University Medical Center Tucson Campus · Tucson, Arizona
- Banner-University Medical Center Tucson Campus · Tucson, Arizona
- The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal · Tucson, Arizona
- University of Arizona Cancer Center - North Campus · Tucson, Arizona
- The University of Arizona Cancer Center-Main · Tucson, Arizona
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