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

NCT06344715 | Recruiting Phase 1

• 1 other identifier: SL-T10-001_P1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• PSA response rate

  Baseline to 48 weeks

• PSA progression free survival

  Baseline to 48 weeks

• Radiographic progression free survival

  Baseline to 48 weeks

• Change of induced T-cell responses for SL-T10 vaccine

  Baseline to 48 weeks

Study Arms (6)

Cohort S1

EXPERIMENTAL

SL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM)

Biological: SL-T10; Biological: GX-I7

Cohort S2

EXPERIMENTAL

SL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM)

Biological: SL-T10; Biological: GX-I7

Cohort a'

EXPERIMENTAL

SL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab

Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab

Cohort A

EXPERIMENTAL

SL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab

Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab

Cohort B

EXPERIMENTAL

SL-T10 (6mg, multiple injections, IM) GX-I7 (720 ug 2 injections, IM) Pembrolizumab

Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab

Cohort C

EXPERIMENTAL

SL-T10 (6mg, multiple injections, IM), GX-I7 (960 ug 2 injections, IM), Pembrolizumab

Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab

Interventions

SL-T10 BIOLOGICAL

A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants

Cohort A; Cohort B; Cohort C; Cohort S1; Cohort S2; Cohort a'

GX-I7 BIOLOGICAL

A T-cell growth factor

Cohort A; Cohort B; Cohort C; Cohort S1; Cohort S2; Cohort a'

Pembrolizumab BIOLOGICAL

An immune check point inhibitor

Cohort A; Cohort B; Cohort C; Cohort a'

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• SL VAXiGEN: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

efineptakin alfa; pembrolizumab

Study Officials

• Cheol Kwak, MD, phD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Chang Wook Jeong, MD, phD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Bok Seo, phD

CONTACT

82-2-6098-2816; clinical@slvaxigen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 3, 2024
• Study Start: October 17, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)