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

NCT07389187 | Not Yet Recruiting Early Phase 1

• 1 other identifier: LC-K76-201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

mCRPC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PSA Response Rate

  From baseline to primary completion, which may take up to 24 to 48 weeks

• Disease control rate (DCR)

  From baseline to primary completion, which may take up to 24 to 48 weeks

• Radiographic Progression-Free Survival (rPFS)

  From baseline to primary completion, which may take up to 24 to 48 weeks

• Time to First Skeletal-Related Event (SRE)

  From baseline to primary completion, which may take up to 24 to 48 weeks

Study Arms (1)

LC-K76 + Tislelizumab + ADT

EXPERIMENTAL

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; Drug: Tislelizumab; Drug: Standard Androgen Deprivation Therapy (ADT)

Interventions

LC-K76 DIETARY_SUPPLEMENT

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

LC-K76 + Tislelizumab + ADT

Tislelizumab DRUG

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

LC-K76 + Tislelizumab + ADT

Standard Androgen Deprivation Therapy (ADT) DRUG

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

LC-K76 + Tislelizumab + ADT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 18 to 85 years.
• Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.
• 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.
• Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).
• Serum testosterone at castration levels (\< 50 ng/dL or 1.75 nmol/L).
• ECOG performance status ≤ 2.
• Life expectancy \> 6 months.
• Adequate bone marrow, hepatic, and renal function.
• Willing to undergo biopsies before and during treatment

You may not qualify if:

• Lack of pathological evidence for prostate cancer.
• Other primary malignant tumors active or requiring treatment within the past 3 years.
• Has visceral metastases.
• Poorly controlled diabetes after continuous insulin therapy.
• 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) .
• Severe cardiopulmonary disease or high-risk conditions.
• Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1).
• Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.
• History of severe drug allergies.
• Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea).
• Concurrent psychiatric or neurological conditions

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Changzheng hospital

Shanghai, Shanghai Municipality, 201109, China

Location

MeSH Terms

Interventions

tislelizumab

Central Study Contacts

Ren, MD,PhD

CONTACT

86021-81886999; renshancheng@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Urology

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)