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A Study of HB0045 Injection in Patients With Advanced Solid Tumors

NCT06056323 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult

Interventions

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.

Sponsors & Collaborators

  • Gabrail Cancer Center Research

    collaborator OTHER

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Shanghai Huaota Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongmin Yang · Shanghai Huaota Biopharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2025-09-19
Completion
2026-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06056323 on ClinicalTrials.gov