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NCT06123494
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen
Phase 3 trial testing SHR-A1811 in HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma in 360 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 360 |
| Start date | 9 January 2024 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR-A1811 — full drug profile →
- Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan — full drug profile →
Conditions studied
- HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma — all drugs for HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry \[IHC\] 3+ or IHC 2+/in situ hybridization \[ISH\]+) gastric or GEJ adenocarcinoma (based on \[American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3 -
Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538 -
Current status and perspectives of esophageal cancer: a comprehensive review.
Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645 -
Antibody-Drug Conjugates and Beyond: Next-Generation Targeted Therapies for Breast Cancer.
Wali AF, El-Tanani M, Talath S, Rabbani SA, et al · · 2025 · cited 1× · PMID 41463194 · DOI 10.3390/cancers17243943 -
Evolving Treatment Landscape for Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma.
Wheless MC, Comer M, Gibson MK. · · 2024 · cited 1× · PMID 39441479 · DOI 10.1007/s11912-024-01607-5 -
Antibodies to watch in 2026.
Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669 -
Trastuzumab deruxtecan in the treatment of HER2-positive gastric cancer: a comprehensive review.
Jubashi A, Nakayama I, Shitara K. · · 2025 · PMID 41257369 · DOI 10.1080/14796694.2025.2589996
Verify or expand the search:
- PubMed search for NCT06123494
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHR-A1811
Trials testing the same drug.
- NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
- NCT07466303 — Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07466927 — Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver · Phase 2 · not yet recruiting
- NCT07382687 — Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer Wit · Phase 3 · not yet recruiting
- NCT07377916 — Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC · NA · not yet recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06123494 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 16 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06123494.
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