NCT06223308

A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors

A Phase I/II Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of HB0028 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a phase I/II open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of HB0028 in patients with advanced solid tumors.

Detailed description

This is a phase I/II, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase I study, the safety and tolerability of HB0028 will be evaluated in patients with advanced solid tumors. In the phase II study, the safety and efficacy of HB0028 at the RP2D will be evaluated in cohorts of patients with specific solid tumors.

Conditions

• Advanced Solid Tumor
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	HB0028	Patients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0028 via intravenous infusion. HB0028 IV every 3 weeks (q3w).

Timeline

• Start date: 2022-09-09
• Primary completion: 2024-05-01
• Completion: 2024-10-01
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

1 site across 1 country: China