NCT04826107

Study of DP303c Injection in Patients With Advanced or Metastatic Gastric Cancer

An Open-label, Multicentre, Phase II Study of DP303c Injection in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Gastric Cancer With HER2 Expression

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter, phase II study to evaluate the efficacy and safety of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer.

Detailed description

This is an open-label, multicenter, phase II study of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer with two parts. In part 1, patients will be treated with DP303c injection at three dose levels (2.0 mg/kg，2.5 mg/kg or 3.0 mg/kg) every 3 weeks to determine the recommended dose . Once the recommended dose has been established in part 1, patients will be enrolled into 4 cohorts in part 2.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	DP303c treatment	DP303c injection, every 3 weeks.
DRUG	DP303c treatment（second-line of HER2-positive）	DP303c injection, every 3 weeks.
DRUG	DP303c treatment （third-line of HER2-positive）	DP303c injection, every 3 weeks.
DRUG	DP303c treatment（≥second-line of HER2 low expressing）	DP303c injection, every 3 weeks.
DRUG	DP303c + PD-1/PD-L1 treatment	DP303c injection + PD-1/PD-L1 injection, dose and frequency to be determined.

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-08-01
• Completion: 2024-12-01
• First posted: 2021-04-01
• Last updated: 2021-04-01