Status and phase
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About
This is a multicenter, dose-escalation/expansion phase 1 trial to evaluate the safety, tolerability and efficacy of SHR3680 with or without SHR3162 given orally to subjects with metastatic castration-resistant prostate cancer (mCRPC).
Full description
This study consists of 2 Part. In the Part 1 (dose escalation phase), up to 4 dose levels of SHR3680 will be investigated with a sequential "3+3" design (3 or 6 participants in each dose level). There will be a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If not dose-limiting toxicities (DLTs) are observed during the 1-week period, SHR3680 administration will resume at the same dose level.
In the Part 2a (expansion phase), up to 9 additional participants will be enrolled at the MTD or recommended phase 2 dose (RP2D). The purpose of the expansion part of the study is to explore the clinical benefits of SHR3680 and to further identify its PK features.
In Part 2b (combination phase), two dose cohorts of SHR3162 combine with SHR3680 at fixed dose will be investigated.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Male 18 years and older
Ability to understand the purposes and risks of the trial and his/her signed informed consent form approved by the HREC of the trial site, which must be obtained before entering the trial
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial
Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the screening visit
Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration)
Progressive disease by PSA or imaging after docetaxel-based chemotherapy or abiraterone in the setting of medical or surgical castration. Prior enzalutamide is allowed as long as patients had a PSA response >50% or were treated for at least 6 months. Disease progression for study entry is defined by one or more of the following three criteria:
ECOG performance status of 0 or 1
Life expectancy of at least 6 months
Able to swallow the study drug and comply with study requirements
Acceptable liver function defined as:
Acceptable renal function defined below:
• Serum creatinine ≤ 1.5 times ULN
Acceptable hematologic status (without hematologic support including hematopoietic factor, blood transfusion) defined below:
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
33 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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