NCT06492915

Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

A Phase Ⅱ Study of Chiauranib Plus Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.

Detailed description

Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance. This study is a phase II, single arm, open label, multi-center study to evaluate the efficacy and safety of chiauranib plus albumin-paclitaxel and gemcitabine as first-line therapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Chiauranib	Chiauranib, 25 mg, 35 mg or 50 mg, oral administration once daily
DRUG	Albumin-paclitaxel Injection	Albumin-paclitaxel Injection, 125 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle
DRUG	Gemcitabine Injection	Gemcitabine Injection, 1000 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-05-31
• Completion: 2026-10-31
• First posted: 2024-07-09
• Last updated: 2026-03-18

Locations

1 site across 1 country: China