drugset / Trial / NCT05958849

Advanced Pancreatic Cancer

NCT05958849

Phase 2 Unknown 30 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-01
Primary completion
2024-07-01
Completion
2025-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Solutumab Unknown 300 mg Intravenous
Subject Sovalteinib Unknown 200 mg Oral
Subject Tegeo Unknown 40 mg
Subject Tegeo Unknown 50 mg
Subject Tegeo Unknown 60 mg

Indications

No indication recorded.