NCT06123494
Recruiting
Phase 3
A Phase 3, Multicenter, Randomized, Open-label Study of SHR-A1811 (HER2-ADC) Compared With the Chemotherapy Treatment Chosen by the Investigators for Subjects With HER2-positive Metastatic and/or Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Who Have Progressed on or After First-line Anti-HER2 Therapy-containing Regimen
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country360 target enrollmentStarted: January 9, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years old, male and female;
- •Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, and unresectable locally advanced or metastatic disease
- •Prior anti-HER-2 containing treatment
- •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);
- •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
- •At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);
- •Expected survival ≥12 weeks;
- •Good blood reserve and liver, kidney and coagulation function;
- •Willing to provide informed consent for study participation.
Exclusion Criteria
- •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;
- •Known allergies to monoclonal antibodies and inactive ingredients of this product, and allergies to paclitaxel, docetaxel, and irinotecan concurrently;
- •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;
- •Clinically active central nervous system metastases;
- •Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •Clinically significant gastrointestinal disorder by the opinion of Investigator;
- •Has a history of immunodeficiency, including a positive HIV test;
- •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;
- •Subjects with interstitial pneumonia or with ≥ grade 3 interstitial pneumonia during prior treatment with immune checkpoint inhibitors;
- •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);
Arms & Interventions
SHR-A1811
Experimental
Intervention: SHR-A1811 (Drug)
The investigators' choice
Active Comparator
Intervention: Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan (Drug)
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: Time from date of randomization until death (due to any cause), up to approximately 42 months
defined as the time from date of randomization until death from any cause.
Secondary Outcomes
- Progression-free survival (PFS)(Time from date of randomization until first objective radiographic disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months)
- Immunogenicity indicators of SHR-A1811: including anti-SHR-A1811 antibodies (ADA and neutralizing antibodies)(approximately 42 months)
- Serum concentrations of SHR-A1811 toxin-binding antibodies and free toxin SHR169265(approximately 42 months)
- Objective response rate (ORR)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- Duration of response (DoR)(Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months)
- Disease control rate (DCR)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- AE and SAE(From time subjects signs informed consent form up to 40 days after last study dose)
Investigators
Study Sites (1)
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