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Status unknownNCT06344715Updated Apr 3, 2024

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

A Phase 1 interventional study of SL-T10 and GX-I7 in Metastatic Castration-resistant Prostate Cancer (mCRPC), sponsored by SL VAXiGEN. Status unknown at 1 site in South Korea. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by SL VAXiGEN · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Oct 2022, registered Mar 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
78
Allocation
Non-randomized
Ages
19 Years and older
Sex
Male
01

Study 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).

Read the 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).

02

Conditions studied

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
03

In context

Lead sponsor

SL VAXiGEN is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Cohort S1

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

    Biological: SL-T10 · Biological: GX-I7

  • Experimental
    Cohort S2

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

    Biological: SL-T10 · Biological: GX-I7

  • Experimental
    Cohort a'

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

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

  • Experimental
    Cohort A

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

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

  • Experimental
    Cohort B

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

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

  • Experimental
    Cohort C

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

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

Interventions

  • BiologicalSL-T10

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

  • BiologicalGX-I7

    A T-cell growth factor

  • BiologicalPembrolizumab

    An immune check point inhibitor

06

What researchers measure

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Baseline to 23 weeks

  2. 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

    Time frame: Baseline to 48 weeks

Secondary outcomes

  1. PSA response rate

    % patients with a reduction in PSA level from baseline by 50% or greater

    Time frame: Baseline to 48 weeks

  2. 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.

    Time frame: Baseline to 48 weeks

  3. 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.

    Time frame: Baseline to 48 weeks

  4. Change of induced T-cell responses for SL-T10 vaccine

    Vaccine-induced T-cell responses assessed by immunoassays in peripheral blood

    Time frame: Baseline to 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Oct 2024, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2024
First posted
Apr 3, 2024
StartActual
Oct 17, 2022
Primary completionEst.
Oct 31, 2024
CompletionEst.
Oct 31, 2024
Last update
Apr 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06344715
Lead sponsor
SL VAXiGEN
Responsible party
Sponsor
First posted
Apr 3, 2024
Start date
Oct 17, 2022
Primary completion
Oct 31, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Apr 3, 2024

Study contacts

Yong Bok Seo, phD
Contact
clinical@slvaxigen.com
82-2-6098-2816
Cheol Kwak, MD, phD
principal investigator · Seoul National University Hospital
Chang Wook Jeong, MD, phD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Pembrolizumab

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SL VAXiGEN

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