NCT04151810

Phase I Clinical Trial of CDP1 in Patients With Advanced Solid Tumors

Phase I Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dragonboat Biopharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study was to evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trials.

Detailed description

OBJECTIVES: Primary: To evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore the dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trial. Secondary: To evaluate the pharmacokinetics of CDP1 in patients with advanced solid tumor. To evaluate the immunogenicity of CDP1 in patients with advanced solid tumor. To evaluate the initial efficacy of CDP1 in patients with advanced solid tumor.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
DRUG	CDP1	Single dose part: Cohort 1:400 mg/m2; Cohort 2: 500 mg/m2; Cohort 3: 750 mg/m2; Multi-dose Part: Starting dose: Cohort 1:400 mg/m2; Cohort 2/3: 500 mg/m2; Maintenance dose: Cohort 1:250 mg/m2, QW; Cohort 2/3: 500 mg/m2, Q2W;
DRUG	CDP1	Starting dose: 400 mg/m2; Maintenance dose: 250 mg/m2,QW;
DRUG	TIP chemotherapy	Paclitaxel: 175 mg/m2 in day 1, Q3W; Ifosfamide: 1200 mg/m2 in day 1, day 2 and day 3, Q3W; Cisplatin: 25 mg/m2 in day 1, day 2 and day 3, Q3W; Participants received TIP chemotherapy up to 6 cycles (21 days per cycle).

Timeline

• Start date: 2019-12-16
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2019-11-05
• Last updated: 2024-08-27

Locations

1 site across 1 country: China