Clinical trialPhase 1Unknown
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor
A Phase I Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Initial Efficacy of SYSA1801 in the Treatment of CLDN 18.2 Positive Advanced Malignant Solid Tumor
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 16 September 2021
- Expected end
- June 2024
- Enrollment
- 272 participants
- Sites
- 1
- Primary outcomes
- Dose-Limiting Toxicity (DLT); Recommended Phase 2 Dose (RP2D); Incidence, severity, and outcome of adverse events (AEs) and serious adverse events (SAEs)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 25 October 2021
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Brief summary public domain (ClinicalTrials.gov)
This is an open-label, dose escalation, dose expansion and extension cohort phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of SYSA1801
Detailed description public domain (ClinicalTrials.gov)
This study includes two stages. The dose escalation and dose expansion part (Stage I) will determine the MTD and RP2D of SYSA1801 in subjects with advanced solid tumor for which there is no available standard likely to confer clinical benefit based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design) The extension cohort (Stage II) will evaluate the preliminary efficacy and safety of SYSA1801 in subjects with Claudin 18.2 positive gastric cancer (GC), gastroesophageal junction (GEJ) cancer, pancreatic cancer, non-small cell lung cancer and other solid tumors who have relapsed and/or are refractory to approved therapies.