Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer

A Phase 1 Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Lutetium (177Lu) DGUL in Combination With Pembrolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (IGNITE Trial)

NCT07244393•Cellbion Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety of the combination therapy of Lutetium (177Lu) DGUL and pembrolizumab. It will also assess the antitumor efficacy and pharmacokinetics of the combination therapy compared to Lutetium (177Lu) DGUL monotherapy. Participants will: Monotherapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals Combination therapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals along with pembrolizumab up to 18 times at 6-week intervals

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male patients aged 19 years or older.

Exclusion Criteria

•Patients with serum testosterone levels meeting castration levels (\< 50 ng/dL) at the screening visit.
•Patients must have experienced disease progression following treatment for mCRPC with a second-generation androgen receptor signaling inhibitor therapy (e.g., abiraterone or enzalutamide).
•Docetaxel treatment is allowed for localised prostate cancer and at mHSPC stage if more than 12 months have elapsed from the last dose of docetaxel, as long as no signs of failure or disease progression occurred during or immediately after such treatment.
•Patients must be receiving hormone deprivation therapy limited to the use of LHRH agonists or LHRH antagonists throughout the study. For patients who have not undergone bilateral orchiectomy, medical castration with an LHRH agonist or antagonist must have been initiated at least 4 weeks prior to baseline and must be maintained for the entire study duration.
•Patients with prostate specific membrane antigen (PSMA)-positive disease, with a maximum standardized uptake value (SUVmax) of at least 20 at a site of disease and greater than 10 at other disease sites measuring ≥ 10mm in longest diameter.
•Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
•Patients with a life expectancy of at least 6 months.
•Patients with adequate hematologic, renal, and liver function, confirmed by the following criteria:
•* Absolute neutrophil count (ANC) ≥ 1,500/μL (without granulocyte colony stimulating factor (G-CSF) administration within 2 weeks prior to baseline)
•* Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to baseline)
+39 more criteria

Key Dates

Start Date

December 1, 2025

Primary Completion Date

April 1, 2029

Completion Date

April 1, 2029

Last Updated

November 24, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Lutetium (177Lu) DGUL

DRUG

Pembrolizumab

DRUG

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

NCT03972657

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Clear Cell Renal Cell Carcinoma (ccRCC)

View study

RECRUITINGPHASE2

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

NCT06134232

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

View study

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: November 24, 2025Data 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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Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer

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

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

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

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

PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA

68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer