NCT06056323

A Study of HB0045 Injection in Patients With Advanced Solid Tumors

A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0045 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, open-label, multicenter study . During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0045. The phase I study will enroll up to 54 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 21 days.

Detailed description

During the phase I study, the safety and tolerability of HB0045 will be evaluated in patients with advanced solid tumors including understanding of the preliminary efficacy. During this phase of the study, DLTs, MTD and MTD range will be observed which will inform RP2D. Phase I:Approximately 54 patients will receive HB0045 as a monotherapy at escalating doses.One cycle is defined as 3 weeks (21 days). In the phase II study, the safety and preliminary efficacy of HB0045 at the RP2D will be evaluated in cohorts of patients with pancreatic, colorectal, ovarian cancer and/or other solid tumors.Phase II:During the dose escalation process, expansion cohorts will be conducted based on the preliminary RP2D.A Simon 2-stage design will be utilized with a stopping rule to allow for early termination of a particular cohort at the end of Stage 1 if patients have insufficient responses to HB0045. During Stage 1, 9 evaluable patients will be enrolled in each cohort; if no responses are observed within the cohort, then the cohort will be discontinued. If at least 1 response is observed, 8 additional evaluable patients will be enrolled in the cohort (Stage 2), for a maximum of 17 evaluable patients per cohort.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HB0045 Drug Product	Patients will be assigned to dose regimens in the order of enrollment and receive their assigned fixed dose of HB0045 via intravenous infusion, Q3W.

Timeline

• Start date: 2023-07-18
• Primary completion: 2025-09-19
• Completion: 2026-03-19
• First posted: 2023-09-28
• Last updated: 2023-10-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study