An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
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.
• The subject voluntarily agrees to participate and has signed the informed consent form.
• Male, aged ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Life expectancy of at least 3 months.
• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Radiologically confirmed metastatic prostate cancer.
• For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression.
• Must have undergone surgical castration or be willing to receive medical castration.
• For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy.
• Adequate function of major organs as defined by the protocol.
• Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).
• Sufficient blood samples must be provided during the screening period for genetic mutation testing.