Clinical trial NCT06344715: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.
Official title: A Phase 1, Multi-center, Open-label, Dose-escalating Study to Evaluate the Safety and Tolerability of Triple Combination Regimen of SL-T10, GX-I7 and Pembrolizumab in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Lead sponsor: SL VAXiGEN
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 78
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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 criteria: Inclusion Criteria:

1. Male patients 19 years of age or older at the date of written informed consent.
2. Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, documented by bone or soft tissue lesions.
3. Patients with castration-resistant prostate cancer with a blood testosterone level of less than 50 ng/dL at the screening visit.
4. patients with metastatic castration-resistant prostate cancer (mCRPC) who meet the following criteria (based on PCWG3.0 modified RECIST 1.1)

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 3) 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

1. 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
2. Advanced soft tissue disease as defined by RECIST 1.1
3. Progressive bone disease defined as ≥2 new lesions on bone scan (per PCWG3)

5. 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:

1. patient has an active autoimmune disease or is receiving systemic steroid therapy or in immunosuppressive status.
2. 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)

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to 23 weeks
measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
timeFrame: Baseline to 48 weeks
Secondary outcomes:
measure: PSA response rate
timeFrame: Baseline to 48 weeks
measure: PSA progression free survival
timeFrame: Baseline to 48 weeks
measure: Radiographic progression free survival
timeFrame: Baseline to 48 weeks
measure: Change of induced T-cell responses for SL-T10 vaccine
timeFrame: Baseline to 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Cheol Kwak, MD, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: