Status:
COMPLETED
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Lead Sponsor:
MacroGenics
Collaborating Sponsors:
Zai Lab (Shanghai) Co., Ltd.
Conditions:
Gastric Cancer
Gastroesophageal Junction Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts. Part A is a si...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
- 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
- Participants receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility
- Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review
- 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
- Key
Exclusion
- 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
- Central nervous system metastases
- Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise
- Prior neoadjuvant or adjuvant treatment with immunotherapy
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04082364
Start Date
September 30 2019
End Date
March 25 2025
Last Update
June 8 2025
Active Locations (73)
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1
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
2
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States, 91010
3
Norris Comprehensive Cancer Center (USC)
Los Angeles, California, United States, 90033
4
Salinas Memorial
Salinas, California, United States, 93901