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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort S1 | Experimental | SL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM) |
|
| Cohort S2 | Experimental | SL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM) |
|
| Cohort a' | Experimental | SL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab |
|
| Cohort A | Experimental | SL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab |
|
| Cohort B | Experimental | SL-T10 (6mg, multiple injections, IM) GX-I7 (720 ug 2 injections, IM) Pembrolizumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SL-T10 | Biological | A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Number of participants with treatment-emergent adverse events (TEAEs) | Baseline to 23 weeks |
| Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 | Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 | Baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate | % patients with a reduction in PSA level from baseline by 50% or greater | Baseline to 48 weeks |
| PSA progression free survival | The interval from the date of randomisation to the date of first evidence of PSA progression or death from any cause, whichever occurred first. |
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Inclusion Criteria:
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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Bok Seo, phD | Contact | 82-2-6098-2816 | clinical@slvaxigen.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheol Kwak, MD, phD | Seoul National University Hospital | Principal Investigator |
| Chang Wook Jeong, MD, phD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
| C582435 | pembrolizumab |
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| Cohort C |
| Experimental |
SL-T10 (6mg, multiple injections, IM), GX-I7 (960 ug 2 injections, IM), Pembrolizumab |
|
| GX-I7 | Biological | A T-cell growth factor |
|
| Pembrolizumab | Biological | An immune check point inhibitor |
|
| Baseline to 48 weeks |
| Radiographic progression free survival | The interval from the date of disease progression on CT and/or Tc bone scan or death from any cause, whichever occurred first. | Baseline to 48 weeks |
| Change of induced T-cell responses for SL-T10 vaccine | Vaccine-induced T-cell responses assessed by immunoassays in peripheral blood | Baseline to 48 weeks |