At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- disitamab vedotin (drug), tucatinib (drug)
- How long the study runs
- Study runs about 62 months (dates as stated)
- About the drug or intervention
- disitamab vedotin — drug: Given into the vein (IV; intravenous) · tucatinib — drug: 300mg given twice daily by mouth (orally)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 54
- Started
- 2024-05-20
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for breast neoplasms
- • Phase2 - 54 participants
- • This clinical trial is studying solid tumor cancers
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast neoplasms
Where?
- • Sutton - The Royal Marsden Hospital
- • Sutton - The Royal Marsden NHS Foundation Trust
- • London - St Bartholomew's Hospital
- • London - The Royal Marsden Hospital
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This clinical trial is to evaluate disitamab vedotin 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-expressing LA/mBC and LA/mGC/GEJC. 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 4 expansion cohorts in subjects with HER2-low LA/mGC/GEJC, HER2+ LA/mGC/GEJC, HER2-low LA/mBC, and HER2+ LA/mBC.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ received a PARP-inhibitor where available and not medically contraindicated
- ✓ intolerance to endocrine therapy or endocrine therapy refractory disease:
- ✓ received pembrolizumab with chemotherapy if available as local standard of care therapy
- ✓ received:
What the study is looking for
- ✓General Inclusion Criteria
- ✓cancer that can be measured on scans according to (standard scan measurements)
- ✓activity scale (ECOG) Performance Status score of 0 or 1
- ✓testing different doses and Optimization Phase Inclusion Criteria
- ✓confirmed by testing a sample diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast...
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (8 UK sites)
The Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
St Bartholomew's Hospital
London EC1M 6BQ, United Kingdom
The Royal Marsden Hospital
London SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust (RM)
London SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4GJ, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
