Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| mCRPC | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LC-K76 | Dietary Supplement | — | UNRESOLVED |
| Standard Androgen Deprivation Therapy (ADT) | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LC-K76 + Tislelizumab + ADT
- 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.
- interventionNames
- Dietary Supplement: LC-K76
- Drug: Tislelizumab
- Drug: Standard Androgen Deprivation Therapy (ADT)
Primary outcomes (1)
- measure
- Incidence of Adverse Events (AEs)
- timeFrame
- From baseline to primary completion, which may take up to 24 to 48 weeks
- description
- 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 (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available