This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer. The study consists of two stages: Phase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined. Phase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol
An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.
An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGMaximum tolerated dose (MTD) (Phase Ib)
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT
Time frame: At the end of Day 28 after the first dose
Maximum administered dose (MAD)(Phase Ib)
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Time frame: At the end of Day 28 after the first dose
recommended phase II dose (RP2D) (Phase Ib)
The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.
Time frame: Through phase Ib completion, an average of 1 year.
The incidence and severity of adverse events (AE) (Phase Ib)
Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0
Time frame: Through phase Ib completion, an average of 1 year.
PSA50 response(Phase II)
Proportion of subjects with ≥ 50% PSA decrease
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
Objective response rate (ORR) (phase II)
Best response until progression, as defined by RECIST 1.1 and PCGW3.
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.