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
| NCT ID | NCT06123494 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 360 participants in total. It began in 2024-01-09 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years old, male and female; 2. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, and unresectable locally advanced or metastatic disease 3. Prior anti-HER-2 containing treatment 4. Progression on or after first-line standard treatment (Prior neoadjuvant or adjuvant therapy can be counted as a line of therapy if the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy); 5. Centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy 6. At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1); 7. ECOG: 0-1; 8. Expected survival ≥12 weeks; 9. Good blood reserve and liver, kidney and coagulation function; 10. Willing to provide informed consent for study participation. Exclusion Criteria: 1. Receive the last dose of anti-cancer therapy(including chemotherapy, radiotherapy, biological therapy, targeted therapy or immunotherapy) within 4 weeks, prior to the first dose; 2. Known allergies to monoclonal antibodies and inactive ingredients of this product, and allergies to paclitaxel, docetaxel, and irinotecan concurrently; 3. The toxicity of prior anti-tumor therapy did not recover to the level specified by CTCAE v5.0 grade evaluation ≤ Grade 1 or inclusion/exclusion criteria; 4. Clinically active central nervous system metastases; 5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Clinically significant gastrointestinal disorder by the opinion of Investigator; 7. Has a history of immunodeficiency, including a positive HIV test; 8. During the screening visits and before the first dose, unexplained fever \> 38.5℃, severe infection (CTC-AE \> Grade 2), and active pulmonary inflammation were indicated by screening imaging; 9. Subjects with interstitial pneumonia or with ≥ grade 3 interstitial pneumonia during prior treatment with immune checkpoint inhibitors; 10. Active hepatitis B(HBV DNA ≥ 500 IU/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA above the lower limit of detection of the analytical method); 11. Clinically significant cardiovascular disease ,such as severe/unstable angina, symptomatic congestive heart failure (NYHA ≥ Class II.), clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, myocardial infarction within 6 months before the first dose, cerebrovascular accident (including transient ischemic attack); QTcF of 12-lead ECG was ≥470 ms; Left ventricular ejection fraction \<50%; Clinically uncontrolled hypertension; 12. Had other malignancies with 5 years; 13. Pregnant or lactating women; 14. Other factors that might have led to drop out the study by the investigator opinion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06123494 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06123494 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 360 participants.
Is NCT06123494 currently recruiting?
Yes, NCT06123494 is actively recruiting participants. Contact the research team at yang.wu.yw96@hengrui.com for enrollment information.
Where is the NCT06123494 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06123494 clinical trial?
NCT06123494 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 360 participants.
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