NCT05519059

Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer

A Multicenter, Single-Arm, Open-Label Phase I Clinical Study of Pelareorep With Paclitaxel in Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Adlai Nortye Biopharma Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This ia a multicenter, Single-Arm, Open-Label Phase I Clinical Study Evaluating the Safety and Tolerability of Pelareorep Combined with Paclitaxel Injection and the Intracorporal Process of Pelareorep in Chinese Patients with Advanced or Metastatic Breast Cancer.

Detailed description

This study will enroll patients with advanced or metastatic breast cancer to assess the safety and tolerability of Pelareorep at 1.5×10\^10, 3.0×10\^10, 4.5×10\^10 (TCID50) combined with paclitaxel to fix the MTD or RP2D.

Conditions

• Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Pelareorep	Pelareorep at 1.5×10\^10 TCID50, 3×10\^10 TCID50, 4.5×10\^10 TCID50 on Day 1/2/8/9/15/16 with Paclitaxel at 80 mg/m\^2 on Day 1/8/15 per cycle

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-09-29
• Completion: 2023-05-30
• First posted: 2022-08-29
• Last updated: 2023-11-22

Locations

1 site across 1 country: China