NCT07389187

Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

An Open-Label, Single-Arm, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.

Conditions

• mCRPC

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	LC-K76	Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.
DRUG	Tislelizumab	Intravenous infusion, 200 mg every 3 weeks (Q3W).
DRUG	Standard Androgen Deprivation Therapy (ADT)	Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2028-06-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China