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

Early Phase 1Not Yet RecruitingNCT07389187

Shanghai Changzheng Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

mCRPC

Interventions

LC-K76DIETARY_SUPPLEMENT

Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.

TislelizumabDRUG

Intravenous infusion, 200 mg every 3 weeks (Q3W).

Standard Androgen Deprivation Therapy (ADT)DRUG

Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Changzheng hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

The Incidence of Adverse Events is defined as the proportion of subjects in a clinical trial who experience at least one Adverse Event (AE) during the defined observation period, which is assessed by CTCAE 5.0.