NCT06521931

A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients

A Single-arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Patients With Lymphoma or Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are: * Is PN20 safe in these patients? * Could these patients potentially benefit from PN20 prevention? Participants will * Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs, * Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.

Detailed description

This is a multicenter, single-arm, open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics and immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Adult Patients With Lymphoma or Solid Tumor. This study was divided into two phase, single-dose and multiple-dose. After single-dose period (21 days), if the subject meets the multiple-dose criteria, he or she can enter the multiple-dose phase for the second cycle of PN20 prevention. Subjects could receive a maximum of two cycles of PN20 prevention.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	PN20	Three dose cohorts: 0.2, 0.5 and 0.75 mg/kg, subcutaneous injections, on Day 1 of chemotherapy cycle before the administration of chemotherapy drugs

Timeline

• Start date: 2023-12-06
• Primary completion: 2025-01-13
• Completion: 2025-01-13
• First posted: 2024-07-26
• Last updated: 2026-03-02

Locations

6 sites across 1 country: China