IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a Single-arm, Open-label, Phase 1b/2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.

• 2\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.

• 3\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).

• 4\. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Locations
Other Locations
China
Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Ruijin Hospital, Shanghai Jiao Tong University School of Medic
sm11998@rjh.com.cn
021-64370045
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2028-06
Participants
Target number of participants: 55
Treatments
Experimental: Experimental arm
IBI343 Combined with Sintilimab Plus SOX
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital
Collaborators: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

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