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
Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Investigational drug(s) / intervention(s)
ATG-022pembrolizumab/KEYTRUDA®CAPOX
ATG-022: 1.8mg/kg Q3W, every 21 days as one cycle
pembrolizumab/KEYTRUDA®: 20mg Q3W, every 21 days as one cycle
CAPOX: 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.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
2. Aged ≥18 years as of the date of consent.
3. Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.
4. Archival tumor tissue sample within 36 months prior to participating in the study or newly obtained biopsy of a tumor lesion not previously irradiated should be provided for testing of CLDN 18.2 and PD-L1 expression for determining the criteria.
5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators.
6. Estimated life expectancy of a minimum of 12 weeks.
Exclusion Criteria:
1. Known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.
2. Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE.
3. Prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (e.g., a period of 5 'halflives'), whichever is the most appropriate as judged by the investigator.
4. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
5. Prior radiotherapy within 4 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. Two weeks or fewer of palliative radiotherapy for non- central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention
6. Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
7. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures≤7 days. No waiting is required following implantable port and catheter placement.
Primary outcome measure(s)
AEs and SAEs — 12 months after the last subject enrolled
DLT — Up to 21 Days Dose Limiting Toxicity
RP2D — Up to 21 Days RP2D= Recommended Phase 2 Dose
Trial sites (30)
Facility
City
Region
Status
Anhui Provincial Hospital
Hefei
Anhui
Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
Beijing Cancer hospital
Beijing
Beijing Municipality
Recruiting
Fujian Provincial Cnacer Hospital
Fuzhou
Fujian
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
Gansu Provincial Cnacer Hospital
Lanzhou
Gansu
Not Yet Recruiting
Cancer Institute&Hospital Chinese Academy of Medical Sciences
Langfang
Hebei
Not Yet Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Anyang Tumor Hospital
Anyang
Henan
Recruiting
The First Affiliated Hospital of Henan Medical Hospital
Xinxiang
Henan
Recruiting
Henan Cnacer Hospital
Zhengzhou
Henan
Not Yet Recruiting
The First Affiliated Hospital of Zhenghzou University
Zhengzhou
Henan
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Tongji Medical College of HUST
Wuhan
Hubei
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Recruiting
Xuzhou Central Hospital
Xuzhou
Jiangsu
Not Yet Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
General Hospital of Ningxia Medical University
Yinchuan
Ningxia
Recruiting
Jinan Central Hospital
Jinan
Shandong
Recruiting
Shandong Cancer Hospital &Institue
Jinan
Shandong
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
Tongren Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
Shanxi provincial cancer hospital
Taiyuan
Shanxi
Recruiting
The First Hospital of Shanxi Medical University
Taiyuan
Shanxi
Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an
Shanxi
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
Tianjin Medical Universuty Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Recruiting
The First Affiliated Hospital of Xiamen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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