NCT04146610

Study of DP303c Administered Intravenously to Subjects With HER2-Positive in Advanced Solid Tumors

A Phase Ia, Multicenter, Open and Dose-increasing Study of DP303c to Evaluate the Safety , Pharmacokinetics, Immunogenicity and Antitumor Activity of Subjects With HER2-Positive Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase Ia, multicenter, open and dose-increasing study of DP303c to evaluate the safety , pharmacokinetics, immunogenicity and antitumor activity of subjects with HER2-positive advanced solid tumors.

Detailed description

Dose escalation study: Primary purpose: To investigate the safety and tolerability of DP303c in subjects with HER2-positive advanced solid tumors . Secondary purpose:1. To characterize the pharmacokinetics(PK) profile of DP303c;2. To assess the preliminary anti tumor activity of DP303c; 3. To characterize immunogenicity of DP303c.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	an antibody drug conjugate	Multiple dose grouping

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-10-31
• Last updated: 2019-10-31

Locations

1 site across 1 country: China