A Phase 1/2 interventional study of ATG-022 and pembrolizumab/KEYTRUDA® in Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, sponsored by Antengene Biologics Limited. Recruiting at 30 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Antengene Biologics Limited · Phase 1/2, Interventional, and Treatment
This is A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This is a phase Ib/II Study of ATG-022 plus pembrolizumab with/without chemotherapy in participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1), unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Both the intervention of ATG022 + Pembrolizumab (A+P) and the intervention of ATG-022 + pembrolizumab + chemotherapy (CAPOX regimen, A+P+C) consist of a Ib and II phase.
Participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and having progressed on or after at least one prior systemic therapy, will be enrolled in the intervention of A + P.
Participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and having not received any prior systemic therapy, will be enrolled in the intervention of A + P + C. The study will be firstly initiated from Ib of the intervention of A+P. The initiation of the intervention of A+P+C will be based on the clinical data of A+P
Antengene Biologics Limited is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ATG-022 · Drug: pembrolizumab/KEYTRUDA®
Drug: ATG-022 · Drug: pembrolizumab/KEYTRUDA® · Drug: CAPOX
1.8mg/kg Q3W, every 21 days as one cycle
20mg Q3W, every 21 days as one cycle
Standard Dose level for CAPOX: Capecitabine 1000 mg/m2 PO BID on Day 1-14, Oxaliplatin 130 mg/m2 IV on Day 1, Cycled every 21 days (3 weeks) for 8 cycles.
AEs and SAEs
Time frame: 12 months after the last subject enrolled
DLT
Dose Limiting Toxicity
Time frame: Up to 21 Days
RP2D
RP2D= Recommended Phase 2 Dose
Time frame: Up to 21 Days
ORR
Overall Response Rate
Time frame: 12 months after the last subject enrolled
DOR
Duration of Response
Time frame: 12 months after the last subject enrolled
PFS
Progression Free Survival
Time frame: 12 months after the last subject enrolled
Plasma concentration of ATG-022 and derived PK paramete
To characterize the PK of ATG-022
Time frame: One year after last patient first dose
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Antengene Biologics Limited