Evaluating a new treatment combination for advanced prostate cancer
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)
This study is testing a new combination treatment for men with advanced prostate cancer to see if it is safe and effective after other treatments have failed.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 19 Years and up |
| Sex | Male |
| Sponsor | SL VAXiGEN Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, pembrolizumab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06344715 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and preliminary efficacy of a combination treatment involving SL-T10, GX-I7, and pembrolizumab in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The trial will include male patients aged 19 and older who have confirmed adenocarcinoma of the prostate and have experienced progression after prior therapies. Participants will receive the treatment regimen and be monitored for any adverse effects and treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients aged 19 years or older with metastatic castration-resistant prostate cancer who have previously undergone taxane therapy.
Not a fit: Patients who have not been diagnosed with metastatic castration-resistant prostate cancer or those who have not received prior taxane therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in advanced prostate cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Cheol Kwak, MD, phD — Seoul National University Hospital
- Study coordinator: Yong Bok Seo, phD
- Email: clinical@slvaxigen.com
- Phone: 82-2-6098-2816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.