Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MacroGenics
With
Zai Lab (Shanghai) Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
1. Prior systemic perioperative treatment is allowed; however the participants must have had a disease-free interval of at least 6 months from end of chemo/surgery
2. Participants receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility
3. Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review
4. Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.
Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing
Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1
Life expectancy ≥ 6 months
At least one radiographically measurable target lesion
Acceptable laboratory parameters and adequate organ function
You may not be if
Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions
* Participants with known MSI-H status
History of allogeneic stem cell or tissue/solid organ transplant
