Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an A
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
| Condition(s) | Gastric or Gastroesophageal Junction Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma |
| Who can participate | Inclusion Criteria: * Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements; * Aged ≥ 18 years AND ≤ 75 years at the time of signing the ICF, male or female; * Histologically or cytologically confirmed advanced Gastric or Gastroesophageal Junction Adenocarcinoma * Locally advanced or metastatic Gastric or Gastroesophageal Junction Adenocarcinoma that has failed or progressed after at least one standard systemic treatment in the past, or has experienced intolerable toxicity (CTCAE≥ grade 3), or has contraindications to standard treatment and is not suitable for radical treatment. * At least one measurab |
| Ages | 18 Days to 75 Days |
| Sex | All |
| Lead sponsor | Shanghai Henlius Biotech |
| Locations | Beijing, China |
| Start date | 2025-09-15 |
| NCT ID | NCT07115485 |
| Official listing | https://clinicaltrials.gov/study/NCT07115485 |