NCT04828616

Study of DP303c Injection in Patients With Advanced Ovarian Cancer

An Open-label, Multicentre, Phase II Study of DP303c Injection in Patients With HER2-expressing Advanced Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicentre, phase II study to evaluate the efficacy and safety of of DP303c injection in patients with HER2-expressing advanced ovarian cancer.

Detailed description

This is an open-label, multicenter, phase II study of DP303c injection in patients with HER2-expressing advanced ovarian cancer with two parts. In part 1, patients will be treated with DP303c injection at two dose levels (2.0 mg/kg or 3.0 mg/kg) every 3 weeks to determine the recommended phase 2 dose (RP2D). Once the RP2D has been established in part 1, patients will be enrolled into 2 cohorts in part 2.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	DP303c injection	DP303c injection, every 3 weeks (Q3W)

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-07-01
• Completion: 2024-07-01
• First posted: 2021-04-02
• Last updated: 2021-04-02

Locations

1 site across 1 country: China