A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811/SHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.

• Age: ≥18 and ≤70 years, both male and female.

• Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.

• Availability of biomarker testing results before enrollment.

• ECOG performance status of 0-1.

• Life expectancy ≥ 6 months.

• Adequate organ and bone marrow function.

• Female participants must be either non-childbearing potential or of childbearing potential with a negative serum pregnancy test within 3 days prior to treatment initiation and not lactating. Childbearing-potential participants and their partners must agree to avoid sperm/ovum donation and comply with contraception requirements from informed consent signing until 8 months after the last dose.

• Voluntarily signed informed consent form, with willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures.

Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
Bin Bai
bin.bai@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2027-05
Participants
Target number of participants: 200
Treatments
Experimental: Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy
Experimental: Cohort B - Adebrelimab in combination with SHR-A1904
Experimental: Cohort D - Adebrelimab in combination with SHR-8068
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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