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
RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGBeijing Cancer hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Provincial Cnacer Hospital
Fuzhou, 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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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGGansu Provincial Cnacer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGCancer Institute&Hospital Chinese Academy of Medical Sciences
Langfang, Hebei, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGAnyang Tumor Hospital
Anyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Henan Medical Hospital
Xinxiang, Henan, China
RECRUITING...and 20 more locations