A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This study is for people with advanced breast cancer or gastric (stomach) cancer that has HER2, a protein that can make cancer grow faster. It's testing a new combination of two drugs: disitamab vedotin and tucatinib. Disitamab vedotin is an antibody drug conjugate (ADC), which is designed to find and kill cancer cells. The main goal is to see how safe this drug combination is and what side effects it might cause. Researchers will also look at how well it works against the cancer. You might be able to join if you have measurable disease and a good general health status. This study plans to enroll about 54 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It will involve a dose escalation phase to find the right dose, followed by a dose optimization phase to further assess safety and effectiveness.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 30 days after their last study treatment, and for laboratory abnormalities for up to 30-37 days after their last study treatment. Overall follow-up for safety and laboratory changes could last approximately 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06157892
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentSeagen, a wholly owned subsidiary of Pfizer
~54 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:disitamab vedotintucatinib
At a glance
Recruiting sites
0 of 135 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose limiting toxicities (DLTs) in dose escalation phase
Measured over Up to 28 days
+4 more outcomes measured
Conditions
Where it's being run
135 sites across 39 statesGeorgia15
Missouri9
New York9
Spain9
Taiwan7
New Jersey6
United Kingdom6
Arizona5
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
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.
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.
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:
Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC
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:
Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
Prior anti-PD-(L)1 therapy is allowed
No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
Must not have received prior treatment with HER2 directed therapy
Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
Locally-advanced, unresectable, or metastatic stage
HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
Participants must have:
Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
Prior T-DXd treatment is allowed
Prior PD1 inhibitor therapy is allowed
No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mGC/GEJC
Exclusion
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
What this trial measures
- Number of participants with dose limiting toxicities (DLTs) in dose escalation phaseUp to 28 days
- Number of participants with adverse events (AEs)Through 30 days after the last study treatment; approximately 5 years
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
- Number of participants with laboratory abnormalitiesThrough 30-37 days after the last study treatment: approximately 5 years
- Number of participants with dose alterationsThrough 30-37 days after the last study treatment: approximately 5 years
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessmentApproximately 3 years
The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.