Adebrelimab with SHR-A1811/SHR-A1904 plus chemotherapy or with SHR-8068 for gastric and gastroesophageal-junction cancer

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

This trial tests whether adding Adebrelimab to SHR-A1811 or SHR-A1904 plus chemotherapy, or combining Adebrelimab with SHR-8068, improves outcomes for adults newly diagnosed with gastric or gastroesophageal-junction cancer who have not yet received treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Adebrelimab, chemotherapy
• Locations: 2 sites (Shijiazhuang, Hebei and 1 other locations)
• Trial ID: NCT07110571 on ClinicalTrials.gov

What this trial studies

This multi-cohort, multicenter Phase II trial enrolls adults with previously untreated gastric or gastroesophageal-junction adenocarcinoma to evaluate two combination regimens: Adebrelimab plus SHR-A1811/SHR-A1904 with chemotherapy, or Adebrelimab plus SHR-8068. Participants must provide recent tumor tissue or archival samples and have available biomarker testing, ECOG performance status 0–1, and adequate organ and bone marrow function. The study measures tumor response rates as well as safety and tolerability across cohorts. Study sites are located in China and participants are followed for efficacy outcomes and adverse events.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed gastric or GEJ adenocarcinoma who are treatment-naïve, have ECOG 0–1, adequate organ function, and can provide tumor tissue and biomarker results are ideal candidates.

Not a fit: Patients who have received prior anti-tumor therapy for gastric/GEJ cancer, have poor performance status (ECOG ≥2), significant organ dysfunction, are pregnant or breastfeeding, or cannot provide required tumor tissue may not receive benefit.

Why it matters

Potential benefit: If successful, these regimens could increase tumor response or disease control compared with current first-line options.

How similar studies have performed: Other trials combining PD-1/PD-L1 inhibitors with chemotherapy have shown benefit in gastric/GEJ cancer, but these particular investigational agents are newer and less well established.

Eligibility criteria

Inclusion Criteria:

1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.
2. Age: ≥18 and ≤70 years, both male and female.
3. Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.
4. Availability of biomarker testing results before enrollment.
5. ECOG performance status of 0-1.
6. Life expectancy ≥ 6 months.
7. Adequate organ and bone marrow function.
8. 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.
9. Voluntarily signed informed consent form, with willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures.

Exclusion Criteria:

1. Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
2. 20% body weight loss within 2 months before enrollment.
3. Prior treatments: Anti-tumor therapy for gastric/gastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during/within 60 days after treatment.
4. Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur/gimeracil/oteracil) or humanized monoclonal antibodies.
5. Other malignancies within 5 years, except curatively treated basal/squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, ductal breast carcinoma in situ, or papillary thyroid cancer.
6. History of immunodeficiency, organ transplantation, or active autoimmune disease.
7. Clinically significant bleeding within 3 months or bleeding predisposition at screening; Arterial/venous thromboembolism within 6 months or at screening.
8. Non-healing wounds, active ulcers, or untreated fractures.
9. Active severe gastrointestinal disorders.
10. Interstitial pneumonia or lung disease.
11. Severe cardiovascular/cerebrovascular diseases or metabolic disorders.
12. Active HBV/HCV infection or HBV-HCV co-infection.
13. Active tuberculosis (TB) within 1 year by history/CT, or prior untreated active TB \>1 year ago.
14. Severe infection within 4 weeks before first dose; CTCAE ≥Grade 2 active infection requiring systemic antibiotics within 2 weeks; Chronic infections potentially affecting treatment/surgery.
15. History of drug abuse or illicit substance use.
16. Other conditions that may increase study risk, confound results, or render the patient unsuitable per investigator judgment.

Where this trial is running

Shijiazhuang, Hebei and 1 other locations

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Bin Bai

Conditions Gastric Cancer; Gastroesophageal-junction Cancer