Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT07389187 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-02-05
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
Interventions
- 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).
Sponsors & Collaborators
-
Shanghai Changzheng Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2026-12-31
- Completion
- 2028-06-30
Countries
- China
Study Locations
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