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Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Sponsor: Shanghai Changzheng Hospital
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.
Official title: 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)
Key Details
Gender
MALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-02
Completion Date
2028-06
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
LC-K76
Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.
Tislelizumab
Intravenous infusion, 200 mg every 3 weeks (Q3W).
Standard Androgen Deprivation Therapy (ADT)
Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).
Locations (1)
Changzheng hospital
Shanghai, Shanghai Municipality, China