A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
- Registration Number
- NCT05417321
- Lead Sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HB0036 HB0036 HB0036 IV every 3 weeks (q3w)
- Primary Outcome Measures
Name Time Method Safety and tolerability 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 Up to 24 Months MTD or OBD and/or RP2D.
- Secondary Outcome Measures
Name Time Method AUC Up to 24 Months Area Under concentration-time Curve (AUC)
Cmax Up to 24 Months Maximum serum concentration (Cmax)
Tmax Up to 24 Months half-life time of maximum concentration
Trial Locations
- Locations (4)
Shandong Hospital
🇨🇳Jinan, Shandong, China
Next Oncology
🇺🇸San Antonio, Texas, United States
Horizon Oncology
🇺🇸Lafayette, Indiana, United States
Summit Cancer Centers
🇺🇸Spokane, Washington, United States