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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.

HB0025

Anthony Tolcher

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.

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.

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

Safety profile including adverse events, changes in safety assessment parameters (e.g. incidence of AEs, vital signs, ECGs, clinical laboratory results and DLTs);

Area Under concentration-time Curve (AUC), Maximum serum concentration (Cmax), Clearance (CL), Volume of distribution (Vd), Mean Residence Time (MRT), half-life (t1/2), time of maximum concentration (Tmax), and average plasma concentration (Cavg).

Overall response rate (ORR) as measured by RECIST v1.1.

Disease control rate (DCR) as measured by RECIST v1.1.

Duration of response (DOR) as measured by RECIST v1.1.

Progression-free survival (PFS) as measured by RECIST v1.1.

Anti-drug antibody (ADA) and neutralizing antibodies (Nab).

Duration of response (DOR) as evaluated by investigators according to RECIST v1.1

Progression-free survival (PFS) as evaluated by investigators according to RECIST v1.1

The 12-month OS rate (OS12m) as evaluated by investigators according to RECIST v1.1

Overall survival (OS) as evaluated by investigators according to RECIST v1.1

Area Under concentration-time Curve (AUC), Maximum serum concentration (Cmax), Clearance (CL), Volume of distribution (Vd), Mean Residence Time (MRT), half-life (t1/2)、time to maximum concentration (Tmax)、and average plasma concentration (Cavg).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Injection HB0025 in Patients With Advanced Solid Tumors	NCT04678908	Tumor, Subjects	HB0025	18 Years -	Huabo Biopharm Co., Ltd.
A Study of Injection HB0025 in Patients With Advanced Solid Tumors	NCT04678908	Tumor, Subjects	HB0025	18 Years -	Huabo Biopharm Co., Ltd.

Spots Global Cancer Trial Database for tumor, subjects