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Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1NCT06344715

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

A Phase 1 study testing SL-T10, GX-I7 and Pembrolizumab in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by SL VAXiGEN at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 19 years and older, men only
What is being tested?
SL-T10, GX-I7 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteSouth Korea
Study dates
17 Oct 2022to 31 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
Show all 9Show fewer
  • Advanced soft tissue disease as defined by RECIST 1.1
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Yong Bok Seo, phD contact

82-2-6098-2816

clinical@slvaxigen.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

Other trials in South Korea

About this study

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)

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).

Being tested
SL-T10, GX-I7, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SL-T10Biological

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

  • GX-I7Biological

    A T-cell growth factor

  • PembrolizumabBiological

    An immune check point inhibitor

Study groups in NCT06344715
Study groupRoleWhat they receive
Cohort S1ExperimentalSL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM)
Receives: Biological: SL-T10; Biological: GX-I7
Cohort S2ExperimentalSL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM)
Receives: Biological: SL-T10; Biological: GX-I7
Cohort a'ExperimentalSL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab
Receives: Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab
Cohort AExperimentalSL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab
Receives: Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab
Cohort BExperimentalSL-T10 (6mg, multiple injections, IM) GX-I7 (720 ug 2 injections, IM) Pembrolizumab
Receives: Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab
Cohort CExperimentalSL-T10 (6mg, multiple injections, IM), GX-I7 (960 ug 2 injections, IM), Pembrolizumab
Receives: Biological: SL-T10; Biological: GX-I7; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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

    Measured: Baseline to 48 weeks

Secondary outcomes (4)

  1. PSA response rate

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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: Baseline to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start17 Oct 2022
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06344715
Sponsor's protocol ID
SL-T10-001_P1
Status last verified
Mar 2024
First submitted
19 Mar 2024
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SL-T10, GX-I7 and Pembrolizumab in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by SL VAXiGEN at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong Bok Seo, phD (82-2-6098-2816, clinical@slvaxigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Baseline to 23 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06344715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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