NCT05706207

A Study of HB0030 Injection in Patients With Advanced Solid Tumors

A Phase Ia,Single Center,Open-label,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of HB0030 Injection in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Huabo Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ia single-center, open-label, dose escalation study.The objectives of this study are to evaluate the safety, toxicity, tolerability, pharmacokinetics/pharmacodynamics(PK/PD), immunogenicity, biomarkers, and antitumor activity of HB0030 in advanced solid tumor subjects.

Detailed description

The phase Ia study will enroll up to 19-36 subjects with advanced solid tumor who have progressing tumor after standard therapy and have no better treatment option.The conventional 3+3 design will be applied for dose escalation.This study will set up 8 dose groups.HB0030 injection is administered once every 3 weeks.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HB0030 injection	0.03 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	0.3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	1 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	10 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	20 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	30 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
DRUG	HB0030 injection	40 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-01-31
• Last updated: 2023-01-31

Locations

1 site across 1 country: China