This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The number of subjects with adverse events/serious adverse events (Phase Ib)
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
Time frame: Throughout phase Ib (approximately 1 year)
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)
A DLT occurs during Cycle 1 (the DLT assessment period) that is assessed as related to study treatment.
Time frame: From first dose of study treatment until the end of Cycle 1.
Recommended phase II dose (RP2D) (Phase Ib)
RP2D will be selected upon safety, PK and efficacy data.
Time frame: Throughout phase Ib (approximately 1 year)
Objective Response Rate (ORR) (Phase II)
Best response until progression, as defined by RECIST 1.1 and PCWG3
Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year)
Objective Response Rate (ORR) (Phase II)
Proportion of subjects with ≥ 50% PSA decrease
Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year).
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