Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

Official Title

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

Details

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.

Keywords

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, Breast Cancer, Gastric Cancer, GC, GEJ, HER2-Low Breast Cancer, HER2-Positive Breast Cancer, Seattle Genetics, Neoplasms, Tucatinib, Disitamab vedotin

Eligibility

Locations

  • Chao Family Comprehensive Cancer Center University of California Irvine accepting new patients
    Orange California 92868 United States
  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
ID
NCT06157892
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 172 study participants
Last Updated