NCT07244393

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)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cellbion Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	Lutetium (177Lu) DGUL	Lutetium (177Lu) DGUL will be administered in 4 doses at 6-week intervals (Q6W), and for patients showing good tolerance, additional 2 doses may be added, for a maximum of 6 doses.
DRUG	Pembrolizumab	Pembrolizumab will be introduced at a dose of 400 mg every 6 weeks, beginning with the second cycle of Lutetium (177Lu) DGUL, and will continue for up to approximately 2 years (18 doses).

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-11-24
• Last updated: 2025-11-24