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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT06157892
Run by: Seagen, a wholly owned subsidiary of Pfizer
People needed: 54
Starts: 2024-05-20
Expected to finish: 2029-07-28
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

General Inclusion Criteria
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Dose Escalation and Optimization Phase Inclusion Criteria
Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
Locally-advanced, unresectable, or metastatic stage
Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
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 intolerance to endocrine therapy or endocrine therapy refractory disease:
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
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.
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.
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:

You may not qualify if…

Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
Prior therapy with ADCs with MMAE payload
Prior therapy with tucatinib
Active CNS and/or leptomeningeal metastasis.
Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications

Where it is running

Banner-University Medical Center Tucson Campus — Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal — Tucson, Arizona, United States
University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
The University of Arizona Cancer Center-Main — Tucson, Arizona, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center — Orange, California, United States
UC Irvine Medical Center — Orange, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies — San Francisco, California, United States
UCLA Department of Medicine - Hematology & Oncology — Santa Monica, California, United States
UCLA Hematology/Oncology - Parkside — Santa Monica, California, United States
Colorado West Healthcare System, dba Community Hospital — Grand Junction, Colorado, United States
Colorado West Healthcare, dba Grand Valley Oncology — Grand Junction, Colorado, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Moffitt Cancer Center - International Plaza — Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
Moffitt McKinley Hospital — Tampa, Florida, United States
Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida, United States
Georgia Cancer Specialists - Athens — Athens, Georgia, United States
Georgia Cancer Specialists - Annex — Atlanta, Georgia, United States
Atlanta Cancer Care - Atlanta — Atlanta, Georgia, United States
Georgia Cancer Specialists-Northside — Atlanta, Georgia, United States
Northside Hospital, Inc.- Central Research Department — Atlanta, Georgia, United States
Northside Hospital — Atlanta, Georgia, United States
Banner-University Medical Center Tucson Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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