NCT04678908

A Study of Injection HB0025 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety and Pharmacokinetics of HB0025 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Huabo Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, dose escalation and expansion study. During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0025. The phase I study will enroll up to 154 subjects with advanced solid tumors who have progressed on or after standard of care therapy and for whom there is no further treatment available that in the judgement of the patient's physician would be beneficial. One cycle is defined as 28 days.

Detailed description

Dose escalation phase Approximately 19 to 74 subjects will receive escalating doses on HB0025 monotherapy. The escalating dose phase is composed of an accelerated titration design and a conventional 3+3 design. During the dose escalation, when a given dose level completes the DLT observation period, an evaluation of PK, PD, biomarkers, tolerability and efficacy will be performed and if this dose level is considered as a possible candidate dose level for OBD. Determination of MTD or OBD will be expanded to a total of 6 subjects (if not already done due to observation of a DLT). After the MTD or OBD is determined, the dose group will continue to recruit subjects until the total number of subjects reaches 10 to confirm that the MTD or OBD is RP2D. Dose escalation phase Approximately 80 subjects will be enrolled into expansion doses on HB0025. During the dose escalation process, dose expansion studies will be conducted based on the preliminary determination of RP2D and the expanded tumor types.

Conditions

• Tumor, Subjects

Interventions

Type	Name	Description
DRUG	HB0025	Patients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0025 via intravenous infusion.

Timeline

• Start date: 2021-03-10
• Primary completion: 2024-02-02
• Completion: 2024-05-23
• First posted: 2020-12-22
• Last updated: 2022-06-01

Locations

6 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study