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)

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.

Inclusion Criteria:

1. Male, aged 18 to 85 years.
2. Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.
3. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and/or docetaxel chemotherapy.
4. Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).
5. Serum testosterone at castration levels (< 50 ng/dL or 1.75 nmol/L).
6. ECOG performance status ≤ 2.
7. Life expectancy > 6 months.
8. Adequate bone marrow, hepatic, and renal function.
9. Willing to undergo biopsies before and during treatment

Exclusion Criteria:

1. Lack of pathological evidence for prostate cancer.
2. Other primary malignant tumors active or requiring treatment within the past 3 years.
3. Has visceral metastases.
4. Poorly controlled diabetes after continuous insulin therapy.
5. Significant abnormalities in laboratory values at randomization (Hb < 90 g/L; Neutrophils < 1.5x10^9/L; Platelets < 75x10^9/L; ALT/AST > 2.5xULN; Bilirubin > 1.5xULN; eGFR < 60 mL/min/1.73m^2) .
6. Severe cardiopulmonary disease or high-risk conditions.
7. Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1).
8. Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.
9. History of severe drug allergies.
10. Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea).
11. Concurrent psychiatric or neurological conditions