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NCT Number: NCT07389187

Safety and Preliminary Efficacy Evaluation 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.

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Key information

Conditions

MCRPC

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LC-K76

Dietary Supplement

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

Tislelizumab

Drug

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).

Primary outcomes

  1. Incidence of Adverse Events (AEs)

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

    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.

Secondary outcomes

  1. PSA Response Rate

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

  2. Disease control rate (DCR)

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

    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) .

  3. Radiographic Progression-Free Survival (rPFS)

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

    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.

  4. Time to First Skeletal-Related Event (SRE)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ren, MD,PhD

CONTACT

[email protected]

86021-81886999

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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