Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT06157892
Eligibility Criteria:
Inclusion Criteria:
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:
* 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
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:
* 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
Cohort D (HER2+ LA/mGC/GEJC) Inclusion Criteria
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06157892
Study Brief:
Protocol Section:
NCT06157892