JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. (NCT07284134) — China Trial Details

Condition(s) studied

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

JS107 for InjectionIrinotecanPaclitaxelDocetaxel

JS107 for Injection: Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).

Irinotecan: Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).

Paclitaxel: Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).

Docetaxel: Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).

Study summary

This is a multicenter, randomized, controlled, open-label, Phase III study, designed to evaluate the efficacy and safety of JS107 versus investigator-selected therapy in the second-line or later treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2.

The study population consists of patients with CLDN18.2-positive, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. The primary endpoints of the study are BICR-assessed progression-free survival and overall survival.

Number of subjects and allocation:This study plans to enroll approximately 560 subjects, who will be randomized in a 1:1 ratio to receive either JS107 (experimental group) or investigator-selected therapy (control group).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: 1. Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance. 2. Age ≥ 18 years, male or female. 3. ECOG PS 0 or 1. 4. Expected survival period≥ 3 months. 5. Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology. 6. Patients who have received at least one prior line of systemic treatments and developed PD, and the previous treatment must include fluorouracil and platinum. 7. Fresh or archival tumor tissue (blocks of formalin-fixed, paraffin-embedded \[FFPE\] tissue or unstained FFPE tumor tissue sections) must be available and comfirmed CLDN18.2 positivity by for central laboratory through immunohistochemistry (IHC) before randomization. 8. Having ≥ 1 measurable lesion according to RECIST v1.1 (per investigator assessment). 9. Any AEs and/or complications caused by previous therapies including surgery or radiotherapy have been adequately resolved to Grade 0 or 1 (per NCI-CTCAE v5.0 criteria) or have been stabilized in the judgment of investigators. Exclusion Criteria: 1. Previous treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody). 2. Previously treated with an ADC loaded with a tubulin inhibitor. 3. Received strong CYP3A inhibitor or inducer within 2 weeks or 5 half-lives prior to randomization, whichever is longer. 4. Use of chemotherapy, immunotherapy or other anti-tumor therapies or participation in other clinical trials within 3 weeks prior to randomization, or use of oral fluorouracil, small molecule targeted drugs or traditional Chinese medicine for gastric cancer within 2 weeks prior to randomization. 5. Major surgery (requiring general anaesthesia and \>24 hours of Hospitalisation) or other clincal trial drug treatment within 4 weeks prior to randomization, or radiotherapy within 2 weeks prior to randomization. 6. Imaging demonstrating brain metastases (except patients who have completed whole brain radiotherapy or local therapy (such as surgery), have discontinued prednisone for at least 4 weeks prior to randomization, and have stable radiologically confirmed tumor lesions and no clinical symptoms of tumor during 4 weeks prior to randomization), metastases to meninges, or spinal cord compression. 7. Tumor invades important surrounding structures (e.g., large blood vessels, trachea, etc.) with high risk of rupture and hemorrhage or airway fistula, or metastases to bone with high risk of paraplegia. 8. Thromboembolic events within 3 months prior to randomization (except patients with non-pulmonary Thromboembolism who do not require treatment or have been stably treated with anticoagulants for 14 days or longer prior to randomization). 9. History of other neoplasm malignant within 5 years prior to randomization, except for neoplasm malignant cured after treatment. 10. Having active autoimmune diseases requiring systemic treatment (i.e., immunologic modulator, corticosteroid, or Immunosuppression) within 2 years prior to randomization; replacement therapy (such as thyroid hormone, Insulin, or physiologic corticosteroid replacement therapy due to adrenal or pituitary insufficiency) is not considered systemic treatment. 11. Known severe allergic reaction to any component in the investigational drug formula.

Primary outcome measure(s)

BICR-PFS — up to 2 years
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Overall Survival — up to 5 years
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.

Trial sites (68)

Facility	City	Region	Status
AnHui Provincial Cancer Hospital	Hefei	Anhui	Not Yet Recruiting
Peking University First Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing Municipality	Not Yet Recruiting
Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital	Fuzhou	Fujian	Not Yet Recruiting
Union Hospital Affiliated to Fujian Medical University	Fuzhou	Fujian	Not Yet Recruiting
The First Hospital of Lanzhou University	Lanzhou	Gansu	Not Yet Recruiting
Gansu Provincial Cancer Hospital	Lanzhou	Gansu	Not Yet Recruiting
Gansu wuwei tumor hospital	Wuwei	Gansu	Not Yet Recruiting
Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	Not Yet Recruiting
Nanfang hospital	Guangzhou	Guangdong	Not Yet Recruiting
The sixth affiliated hospital sun yat-sen university	Guangzhou	Guangdong	Not Yet Recruiting
Meizhou People's Hospital（Huangtang Hospital）	Meizhou	Guangdong	Not Yet Recruiting
Cancer Hospital of Shantou University Medical College	Shantou	Guangdong	Recruiting
Cancer Hospital Affiliated to Guangxi Medical University	Nanning	Guangxi	Not Yet Recruiting
People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi	Not Yet Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Langfang Campus	Langfang	Hebei	Not Yet Recruiting
The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	Not Yet Recruiting
Affiliated Hospital of North China University of Technology	Tangshan	Hebei	Not Yet Recruiting
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	Not Yet Recruiting
Anyang Tumor Hospital	Anyang	Henan	Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science & Technology	Luoyang	Henan	Not Yet Recruiting
Nanyang First People's Hospital National Third Class A Hospltal	Nanyang	Henan	Not Yet Recruiting
Puyang People's Hospital	Puyang	Henan	Not Yet Recruiting
Sanmenxia Central Hospital	Sanmenxia	Henan	Not Yet Recruiting
Henan Cancer Hospital	Zhengzhou	Henan	Not Yet Recruiting
The First Affiliated Hospital of Zhengzhouuniversity	Zhengzhou	Henan	Not Yet Recruiting
Zhoukou Central Hospital	Zhoukou	Henan	Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University	Wuhan	Hubei	Not Yet Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	Not Yet Recruiting
Hubei Cancer Hospital	Wuhan	Hubei	Not Yet Recruiting
Xiangyang Cancer Hospital	Xiangyang	Hubei	Not Yet Recruiting
Yichang Central People's Hospital	Yichang	Hubei	Not Yet Recruiting
Xiangya Hospital of Central South University	Changsha	Hunan	Not Yet Recruiting
Hunan Cancer Hospital	Changsha	Hunan	Not Yet Recruiting
Baotou Tumor Hospital	Baotou	Inner Mongolia	Not Yet Recruiting
Jiangsu Province Hospital	Nanjing	Jiangsu	Not Yet Recruiting
Affiliated Hospital Of Jiangnan University	Wuxi	Jiangsu	Not Yet Recruiting
Xuzhou Central Hospital	Xuzhou	Jiangsu	Not Yet Recruiting
Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	Not Yet Recruiting
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)	Nanchang	Jiangxi	Not Yet Recruiting

+ 28 more sites — see the full list on the official registry below.

More Shanghai Junshi Bioscience Co., Ltd. trials in China

Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy Recruiting

A Randomized, Open-Label, Multicenter Phase III Clinical Study of JS203 Plus Chemotherapy Versus Rituximab Plus Chemotherapy in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Starting soon

Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy Recruiting

Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC Active, not recruiting

Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study Recruiting

Other trials for the same condition

A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Starting soon

Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy Active, not recruiting