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.

Study Overview

• Status: Not yet recruiting
• Conditions: mCRPC
• Intervention / Treatment: Dietary supplement: LC-K76; Drug: Tislelizumab; Drug: Standard Androgen Deprivation Therapy (ADT)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ren, MD,PhD; Phone Number: 86021-81886999; Email: renshancheng@gmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201109
      • Changzheng hospital
      • Contact: Shancheng Ren, PhD/MD; Phone Number: 86021-81886999; Email: renshancheng@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LC-K76 + Tislelizumab + ADT; 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to primary completion, which may take up to 24 to 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA Response Rate		From baseline to primary completion, which may take up to 24 to 48 weeks
Disease control rate (DCR)	Defined as the proportion of subjects whose best overall response, assessed per RECIST 1.1 and PCWG3, is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) .	From baseline to primary completion, which may take up to 24 to 48 weeks
Radiographic Progression-Free Survival (rPFS)	Defined as the time from treatment initiation to the first objective evidence of disease progression as assessed by radiographic imaging, or death from any cause, whichever occurs first.	From baseline to primary completion, which may take up to 24 to 48 weeks
Time to First Skeletal-Related Event (SRE)	Defined as the interval from the date of treatment initiation to the date of the first occurrence of any of the following clinically significant events attributable to bone metastasis: pathological fracture (vertebral or non-vertebral), palliative radiation therapy to bone for pain relief, surgical intervention to bone to prevent or treat a fracture or spinal cord compression, or confirmed spinal cord compression.	From baseline to primary completion, which may take up to 24 to 48 weeks

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tislelizumab
• Other Study ID Numbers: LC-K76-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No