Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344715
• Other study ID #: SL-T10-001_P1
• Status: Recruiting
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: SL VAXiGEN
• Contact: Yong Bok Seo, phD
• Phone: 82-2-6098-2816
• Email: clinical[@]slvaxigen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Biological:
• SL-T10
A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants
• GX-I7
A T-cell growth factor
• Pembrolizumab
An immune check point inhibitor

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SL VAXiGEN

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (TEAEs)	Number of participants with treatment-emergent adverse events (TEAEs)	Baseline to 23 weeks
Primary	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
Secondary	PSA response rate	% patients with a reduction in PSA level from baseline by 50% or greater	Baseline to 48 weeks
Secondary	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.	Baseline to 48 weeks
Secondary	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
Secondary	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