NCT05958849

Advanced Pancreatic Cancer

A Single-arm, Open, Single-center Clinical Study of Sovalutinib in Combination With Solutumab and Tegeo in Second and Second Line for Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open, single-center clinical study to observe and evaluate the efficacy and safety of sovalteinib in combination with solutumab and tegeo in second-line and post-line treatment of patients with advanced pancreatic cancer. A total of 30 patients were enrolled in this study, which was divided into 3 phases: screening phase, treatment phase and follow-up phase. During the treatment period, tumor status was evaluated by imaging methods every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during patient treatment) or intolerable toxicity, and tumor treatment and survival status after disease progression were recorded. Safety observations included AE, changes in laboratory test values, vital signs, and changes in ECG. In addition, 10 ml of blood was drawn for testing in our laboratory before each treatment and at the time of disease progression before the patients were enrolled, and the exploration of the efficacy-related biomarker BRCA1 was performed by blood samples.

Conditions

• Progression-free Survival

Interventions

Type	Name	Description
DRUG	Sovalteinib Solutumab Tegeo	Soventinib in combination with solutumab and tegeo for advanced pancreatic cancer

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-07-01
• Completion: 2025-07-30
• First posted: 2023-07-25
• Last updated: 2023-07-25