NCT06055153

DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC

DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With Locally Advanced or Metastatic HER2 IHC2+/3+ Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, exploratory clinical study.

Detailed description

This is a single-arm, exploratory clinical study. Aim to explore the safety and efficacy of Vedicetuzumab combined with an immune checkpoint inhibitor (carrellizumab) and platinum-based first-line treatment for locally advanced/metastatic HER2 overexpression (IHC 2+/3+) esophageal squamous cell carcinoma.

Conditions

• Esophageal Squamous Carcinoma
• HER-2 Protein Overexpression

Interventions

Type	Name	Description
DRUG	RC48+PD-1+platinum-based	Phase I: Three subjects with HER2 overexpression (IHC 2+/3+) were initially enrolled. If dose-limiting toxicity (DLT) was observed in two of the three subjects, the study was continued from dose 1 to dose 2. If ≤1 DLT is observed in 3 subjects, continue to enroll 3 patients, and if ≤2 DLT is observed in 6 subjects, proceed to the second phase. If \> 2 cases of DLT are observed in 6 subjects, adjust to dose 2 for phase 2. Dose 1: RC48 2.5mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks Dose 2: RC48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks The second stage: sample size expansion stage. RP2D obtained at stage 1 continues to be enrolled in up to 20 patients until disease progression or intolerable toxicity occurs.

Timeline

• Start date: 2023-09-30
• Primary completion: 2025-02-28
• Completion: 2025-04-30
• First posted: 2023-09-26
• Last updated: 2023-09-26