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

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2027-06-30

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.

Conditions

HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811

Group Type: EXPERIMENTAL

SHR-A1811

Intervention Type: DRUG

SHR-A1811 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle

The investigators' choice

Group Type: ACTIVE_COMPARATOR

Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan

Intervention Type: DRUG

Ramucirumab 8mg/kg，D 1,15 + Paclitaxel 80mg/m2，D1,8,15，Q4W; Paclitaxel 80mg/m2，D1,8,15，Q4W; Docetaxel 75mg/m2，D1，Q3W; Irinotecan 150mg/m2，D1，Q2W.

Interventions

SHR-A1811

SHR-A1811 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle

Intervention Type: DRUG

Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan

Ramucirumab 8mg/kg，D 1,15 + Paclitaxel 80mg/m2，D1,8,15，Q4W; Paclitaxel 80mg/m2，D1,8,15，Q4W; Docetaxel 75mg/m2，D1，Q3W; Irinotecan 150mg/m2，D1，Q2W.

Intervention Type: DRUG

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Wu

Role: CONTACT

yang.wu.yw96@hengrui.com

0518-82342973

Facility Contacts

Jin Li

Role: primary

lijin@csco.org.cn

+86-21-38804518

Other Identifiers

SHR-A1811-308

Identifier Type: -

Identifier Source: org_study_id