Actively Recruiting
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 AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Antengene Biologics Limited · Updated on 2026-04-14
132
Participants Needed
30
Research Sites
165 weeks
Total Duration
On this page
Sponsors
A
Antengene Biologics Limited
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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 AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent given before any study procedures
- Age 18 years or older at time of consent
- Confirmed gastric or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative, and PD-L1 positive expression
- Provide tumor tissue sample within 36 months or new biopsy for CLDN 18.2 and PD-L1 testing
- At least one measurable tumor lesion per RECIST v1.1
- Estimated life expectancy of at least 12 weeks
You will not qualify if you...
- Active central nervous system metastases or carcinomatous meningitis, unless previously treated and stable for at least 4 weeks without steroids for 14 days
- Prior treatment with CLDN 18.2 ADC, CLDN 18.2 CAR T-cell therapy, or MMAE-containing agents
- Systemic anticancer therapy including investigational agents within 4 weeks before first study dose or until clearance
- Prior immunotherapy discontinued due to Grade 3 or higher immune-related adverse events (except treatable endocrine disorders), Grade 2 myocarditis, or recurrent Grade 2 pneumonitis
- Radiotherapy within 4 weeks before study start or with toxicities requiring corticosteroids (except limited palliative radiotherapy given at least 7 days before first dose)
- Live or live-attenuated vaccine within 30 days before first dose (killed vaccines allowed)
- Major surgery within 28 days or minor surgery within 7 days before first study dose, excluding vascular access placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
3
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Fujian Provincial Cnacer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
5
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Not Yet Recruiting
6
Gansu Provincial Cnacer Hospital
Lanzhou, Gansu, China
Not Yet Recruiting
7
Cancer Institute&Hospital Chinese Academy of Medical Sciences
Langfang, Hebei, China
Not Yet Recruiting
8
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
9
Anyang Tumor Hospital
Anyang, Henan, China
Not Yet Recruiting
10
The First Affiliated Hospital of Henan Medical Hospital
Xinxiang, Henan, China
Not Yet Recruiting
11
Henan Cnacer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
12
The First Affiliated Hospital of Zhenghzou University
Zhengzhou, Henan, China
Not Yet Recruiting
13
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
14
Tongji Medical College of HUST
Wuhan, Hubei, China
Not Yet Recruiting
15
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
16
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
17
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Not Yet Recruiting
18
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
19
The First Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
20
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Not Yet Recruiting
21
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
22
Shandong Cancer Hospital &Institue
Jinan, Shandong, China
Not Yet Recruiting
23
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
24
Tongren Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
25
Shanxi provincial cancer hospital
Taiyuan, Shanxi, China
Actively Recruiting
26
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Not Yet Recruiting
27
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an, Shanxi, China
Not Yet Recruiting
28
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
29
Tianjin Medical Universuty Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
30
The First Affiliated Hospital of Xiamen University
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
T
Tingting Yu
CONTACT
S
Sunny He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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