A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- HB0036
- Conditions
- Advanced Solid Tumor
- Sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Safety and tolerability
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects 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 HB0036 will be evaluated in patients with advanced solid tumors. In the phase Ⅱ study, the safety and efficacy of HB0036 at the RP2D will be evaluated in cohorts of patients with NSCLC and/or other solid tumors. A Safety Review Committee (SRC) will be established throughout the study period, consisting of the principal investigator, representatives of the contract research organization (CRO) (medical inspectors and other relevant personnel), and the Sponsor's medical monitor. The SRC will evaluate safety data based on the study process. The SRC may recommend extended doses, possible changes in the frequency of administration, and extended tumor types for safety reasons based on existing studies prior to starting the phase II study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
HB0036
HB0036 IV every 3 weeks (q3w)
Intervention: HB0036
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: Up to 12 Months
Number of participants with a Dose Limiting Toxicity (DLT) \[ Time Frame: During the first 21 days \]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug.
MTD
Time Frame: Up to 24 Months
MTD or OBD and/or RP2D.
Secondary Outcomes
- AUC(Up to 24 Months)
- Cmax(Up to 24 Months)
- Tmax(Up to 24 Months)