LC-K76 plus tislelizumab for advanced prostate cancer that has stopped responding to treatment
Tests LC-K76 with tislelizumab in men whose metastatic prostate cancer progressed.
Plain-language title generated from the registry record
Registry title: Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07389187, who can take part
Where in China
- Changzheng HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Changzheng Hospital
- Trial code
- NCT07389187
- Record updated
- 5 February 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1); Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts; Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea); Concurrent psychiatric or neurological conditions; Lack of pathological evidence for prostate cancer; Other primary malignant tumors active or requiring treatment within the past 3 years; Poorly controlled diabetes after continuous insulin therapy; Severe cardiopulmonary disease or high-risk conditions; History of severe drug allergies; 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) ; Has visceral metastases.