NCT05148195

A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors

An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-cohort, multicenter Phase II study, the purpose of this study is to assess the efficacy and safety of envofolimab in combination with BD0801 injection with/without chemotherapy for the treatment of advanced solid tumors

Detailed description

The efficacy of immune checkpoint inhibitors combined with antivascular agents has been preliminarily demonstrated in a variety of solid tumors. Based on the huge clinical needs, the efficacy of envofolimab combined with BD0801 in patients with advanced hepatocellular carcinoma, non-small cell lung cancer and advanced colorectal cancer deserves further exploration.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Envofolimab	300mg，Q3W (arm A,B and C)or 200mg, Q2W(arm D)
DRUG	BD0801	2mg/kg，Q3W(armA, B and C) or 2mg/kg，Q2W
DRUG	Docetaxel	75mg/m2，Q3W
DRUG	Irinotecan	180 mg/m2，Q2W
DRUG	Leucovorin calcium	400mg/m2，Q2W
DRUG	5-Fluorouridine	2400 mg/m2，Q2W

Timeline

• Start date: 2021-12-22
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2021-12-08
• Last updated: 2024-03-13

Locations

24 sites across 1 country: China