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

Naval Military Medical University (Second Military Medical University)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: mCRPC

Treatments: Drug: Tislelizumab; Drug: Standard Androgen Deprivation Therapy (ADT); Dietary Supplement: LC-K76

Study type: Interventional

Funder types: Other

Identifiers

NCT07389187

LC-K76-201

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

LC-K76 + Tislelizumab + ADT

Experimental group

Description:

Participants receive oral LC-K76 combined with intravenous Anti-PD-1 monoclonal antibody (Tislelizumab) and standard androgen deprivation therapy (ADT). Treatment continues for 24 weeks.

Treatment:

Dietary Supplement: LC-K76

Drug: Standard Androgen Deprivation Therapy (ADT)

Drug: Tislelizumab