SHR-A1811 with adebrelimab and chemotherapy for untreated advanced gastric or gastroesophageal junction adenocarcinoma

A Phase III, Randomized, Multicenter, Open-label Study to Evaluate SHR-A1811 in Combination With Chemotherapy and Adebrelimab Versus Trastuzumab in Combination With Chemotherapy and Pembrolizumab in Patients With Previously Untreated, Unresectable, Locally Advanced or Metastatic, Gastric or Gastroesophageal Junction Adenocarcinoma Expressing

This trial will test whether adding SHR-A1811 to adebrelimab and standard chemotherapy helps people with untreated, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma respond better or live longer than current first-line treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Shenyang, Liaoning and 1 other locations)
• Trial ID: NCT07118527 on ClinicalTrials.gov

What this trial studies

This randomized Phase III trial compares a combination of SHR-A1811, adebrelimab, and standard chemotherapy against standard first-line regimens in patients with untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Eligible participants must have measurable disease, provide tumor tissue (new samples preferred), and have ECOG performance status 0–1 with adequate organ and marrow function. Treatment arms use commonly used chemotherapy backbones such as CAPOX or FP and may include trastuzumab and pembrolizumab per standard indications while the investigational arm adds SHR-A1811 plus adebrelimab. The study is being run at major hospitals in China and compares efficacy and safety outcomes between the investigational combination and current standard therapies.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed, untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, ECOG 0–1, measurable disease, adequate organ function, and willing to provide tumor tissue and use effective contraception are ideal candidates.

Not a fit: Patients who have received prior systemic therapy for advanced disease, have ECOG >1, poor organ function, cannot provide tumor samples, or cannot comply with contraception requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could improve response rates and survival compared with current first-line options for these patients.

How similar studies have performed: Prior phase III trials combining immune checkpoint inhibitors with chemotherapy in first-line gastric cancer have shown improved outcomes, so this approach builds on existing positive data while SHR-A1811 itself remains investigational.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 75 years (inclusive), male or female
2. Histologically or cytologically confirmed untreated, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
3. ECOG performance status score of 0 to 1.
4. Body weight ≥ 35 kg.
5. Life expectancy ≥12 weeks.
6. Must have at least one measurable lesion according to RECIST v1.1 criteria.
7. Tumor tissue samples must be provided, and newly obtained tumor tissues are preferred.
8. Adequate bone marrow and organ function；
9. Women of childbearing potential must agree on abstinence (avoid heterosexual sex) or use of the highly effective methods of contraception from the signature of informed consent form until at least 7 months after the last dose of the investigational product(s).
10. Male patients whose partners are women of childbearing potential must agree on abstinence or use of the highly effective methods of contraception from the signature of informed consent form until at least 7 months after the last dose of investigational product(s).
11. Capable of giving informed consent, have signed and dated the informed consent approved by the Ethics Committee, and willing and able to comply with tests and other procedures at scheduled visits.

Exclusion Criteria:

1. Current or previous meningeal metastases; presence of active brain metastases.
2. Ascites, pleural effusion and pericardial effusion requiring treatment (such as puncture, drainage, etc.) within 2 weeks before randomization.
3. Subjects with other malignant tumors within 3 years before randomization.
4. Have received traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization.
5. With adverse reactions (ARs) from previous anti-tumor treatment that have not recovered to NCI-CTCAE v5.0 Grade ≤ 1.
6. Use of other non-marketed clinical investigational products or interventions within 4 weeks before randomization.
7. Have undergone major surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before randomization.
8. Patients with active autoimmune diseases or history of autoimmune diseases.
9. Patients with known or suspected interstitial lung disease; patients with other severe lung diseases that seriously affect respiratory function within 3 months before randomization.
10. History of active tuberculosis within 1 year before randomization, or history of active tuberculosis over 1 year without appropriate treatment.

11、14. History of immunodeficiency, including positive HIV test; active hepatitis B or hepatitis C.

12、Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.

13、Severe cardiovascular or cerebrovascular diseases. 14、Active bleeding (CTCAE Grade ≥ 2). 15、Gastrointestinal perforation, gastrointestinal fistula or abdominal infection within 3 months before randomization.

16、Uncontrollable tumor-related pain or symptomatic hypercalcemia. 17、Patients with Grade \> 1 peripheral neuropathy. 18、Vaccination of live attenuated vaccine within 28 days prior to randomization.

19、Previous use of anti-HER2 antibody-drug conjugates.

Where this trial is running

Shenyang, Liaoning and 1 other locations

• The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Zhongshan Hospital，Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shi Wei SUN

Conditions Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma