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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Fujian Provincial Cnacer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
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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Gansu Provincial Cnacer Hospital
Lanzhou, Gansu, China
Cancer Institute&Hospital Chinese Academy of Medical Sciences
Langfang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan Medical Hospital
Xinxiang, Henan, China
...and 20 more locations