drugset
drugset / Trial / NCT05898373

Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic SDC

NCT05898373 ↗

Phase 1/2 Unknown 120 enrolled Peking Union Medical College
RandomizedCrossoverSingle-blindTreatment

Summary

(1) To apply Bayesian statistics to screen for the most effective treatment regimen containing recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent vedicitumomab (Edisil, RC48) for locally advanced or metastatic salivary gland ductal carcinoma expressing HER2 in the near future. (2) To explore biomarkers relevant to the efficacy of recombinant humanized anti-HER2 monoclonal antibody-MMAE-coupled vedicitumomab (Edisil, RC48) in the treatment of HER2-expressing locally advanced or metastatic salivary gland ductal carcinoma.

Timeline

Start
2023-06-07
Primary completion
2025-06-06
Completion
2026-06-06

Drugs

EvaluationDrugModalityDoseRoute
Subject pyrrolizidine Unknown 400 mg Oral
Subject teraplizumab Unknown 3 mg/kg Intravenous
Subject vedicitumomab Monoclonal antibody 2 mg/kg Intravenous
Subject vedicitumomab Monoclonal antibody 2.5 mg/kg Intravenous
Background Carboplatin Small molecule 200 mg/m2 Intravenous
Background Carboplatin Small molecule 250 mg/m2 Intravenous
Background Cisplatin Other / unclassified 50 mg/m2 Intravenous

Indications

salivary gland cancer