Treatment for HER2-positive gastric cancer after first-line therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of SHR-A1811 in patients with HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma who have progressed after receiving first-line anti-HER2 therapy. Participants will receive SHR-A1811 and be compared to a treatment chosen by their healthcare provider. The study aims to determine if SHR-A1811 can provide better outcomes than existing treatment options for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yang Wu
• Email: yang.wu.yw96@hengrui.com
• Phone: 0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining SHR-A1811 with chemo and immunotherapy for advanced HER2-expressing stomach and gastroesophageal junction cancer

  This trial will test whether combining SHR-A1811 with chemotherapy and/or immunotherapy helps adults with advanced or metastatic HER2-expressing stomach or gastroesophageal junction cancer.

  Recruiting Phase 2 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Shanghai, Shanghai Municipality · NCT05671822

• Glumetinib plus albumin-bound docetaxel for advanced stomach/GEJ cancer and other solid tumors

  This trial tests whether adding Glumetinib to albumin-bound docetaxel helps adults with advanced gastric or gastroesophageal junction adenocarcinoma and other MET-positive solid tumors.

  Recruiting Phase 2 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Hangzhou, Zhejiang · NCT06947291

• Combination therapy of Disitamab Vedotin and Trastuzumab for HER2 positive gastric cancer

  This study is testing a new combination of two drugs, Disitamab Vedotin and Trastuzumab, to see if it can help people with advanced HER2 positive gastric cancer who haven't responded to other treatments.

  Recruiting Phase 1/2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06572319

• Iparomlimab and Tuvonralimab (QL1706) plus SOX versus SOX alone for locally advanced gastric or gastroesophageal junction adenocarcinoma

  This trial will test whether adding the immunotherapy combination Iparomlimab and Tuvonralimab (QL1706) to standard SOX chemotherapy before and after surgery helps people with locally advanced gastric or gastroesophageal junction adenocarcinoma achieve complete tumor remission.

  Recruiting Phase 2 Shandong Provincial Hospital · Jinan, Shandong · NCT06829797

• Low‑dose interval radiation plus tirelizumab and SOX chemotherapy before surgery for locally advanced stomach or gastroesophageal junction adenocarcinoma

  This will test whether short‑course low‑dose radiation combined with the immunotherapy drug tirelizumab and SOX chemotherapy before surgery helps adults with locally advanced stomach or gastroesophageal junction adenocarcinoma.

  Recruiting Phase 2 Shandong Provincial Hospital · Jinan, Shandong · NCT06766578

• ATG-022 vs investigator's choice for CLDN18.2-positive advanced gastric/GEJ cancer

  This trial tests ATG-022 against the doctor’s choice of treatment in adults whose advanced gastric or gastroesophageal junction cancer has CLDN18.2 and who have already tried at least two prior therapies.

  Recruiting Phase 3 Antengene Corporation · Bengbu, Anhui and 130 other locations · NCT07795346

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.