Overview
The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).
Description
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SL-T10, GX-I7, and pembrolizumab in combination in patients with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility
Inclusion Criteria:
- Male patients 19 years of age or older at the date of written informed consent.
- Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, documented by bone or soft tissue lesions.
- Patients with castration-resistant prostate cancer with a blood testosterone level of less than 50 ng/dL at the screening visit.
- patients with metastatic castration-resistant prostate cancer (mCRPC) who meet the
following criteria (based on PCWG3.0 modified RECIST 1.1)
- Prior taxane therapy for metastatic prostate cancer or confirmed refusal or inadequacy of such therapy 2) Patients who have received prior docetaxel and at least one of the following agents: abiraterone acetate or enzalutamide before or after docetaxel treatment
- Patients with progression of prostate cancer during/after prior therapy, in the investigator's judgment, with either of the following, in the internal or external castration state
- PSA progression defined as at least 2 PSA level increases (≥1 week interval between
each test) and a PSA level of ≥2 ng/mL at Screening
- Advanced soft tissue disease as defined by RECIST 1.1
- Progressive bone disease defined as ≥2 new lesions on bone scan (per PCWG3)
- Patients who are on androgen deprivation therapy (ADT) of any kind (patients who have not undergone bilateral orchiectomy must begin internal castration therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or anti-androgenic agents, at least 4 weeks prior to Baseline and must continue for the entire duration of the study)
Exclusion Criteria:
- patient has an active autoimmune disease or is receiving systemic steroid therapy or in immunosuppressive status.
- Patient has history of chemotherapy, radiation chemotherapy, biological therapy, immunotherapy, or radiation therapy within 4 weeks prior to the screening visit (In case of nitrosoureas or mitomycin, 6 weeks prior to the screening visit)