This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer.
This is a multicenter, open label phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic profile of BH009 in patients with advanced squamous head and neck cancer (non-nasopharyngeal) and ovarian cancer, and to initially explore its clinical effectiveness. This study will use a "3+3" dose escalation design to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of BH009.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Every 28 days constitutes a treatment cycle, and administration on day 1, day 8, day 15 of each cycle
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All adverse events (AE) defined by CTCAE version 5.0
Time frame: first dose to 30 days after last dose
Recommended phase 2 dose of BH009
defined by CTCAE version 5.0
Time frame: first dose to 30 days after last dose
MTD of BH009
When the dose is incremented beyond the MTD, the previous lower dose group will be identified as the MTD.
Time frame: first dose to 30 days after last dose
Objective response rate
Objective response rate by RECIST version 1.1
Time frame: After first dose until 30 days after last dose
Duration of relief
Duration of relief by RECIST version 1.1
Time frame: After first dose until 30 days after last dose
Disease control rate
Disease control rate by RECIST version 1.1
Time frame: After first dose until 30 days after last dose
Progression-free survival
Disease control rate by RECIST version 1.1
Time frame: After first dose until 30 days after last dose
PK Analysis of BH009
Maximum Concentration (Cmax)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, China
RECRUITINGObstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGPK Analysis of BH009
Time to Cmax (Tmax)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion
PK Analysis of BH009
Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUC0-last)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion
PK Analysis of BH009
Area Under the Curve From Time 0 Hours to Infinity (AUC0-inf)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion
PK Analysis of BH009
Apparent Terminal Elimination Half-Life (t1/2)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion
PK Analysis of BH009
Apparent Total Clearance (CL)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion
PK Analysis of BH009
Apparent Volume of Distribution (Vz/F)
Time frame: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion