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

RECRUITINGPHASE1

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

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)

NCT06344715•SL VAXiGEN

View on ClinicalTrials.gov

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).

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).

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

October 17, 2022

Primary Completion Date

October 31, 2024

Completion Date

October 31, 2024

Last Updated

April 3, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

SL-T10

BIOLOGICAL

GX-I7

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Contacts

Yong Bok Seo, phD

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC

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