NCT07389187Not yet recruitingEarly phase 1
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 · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 28 Dec 2025
- Start date
- Feb 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07389187
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From Feb 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Lab values
- 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) .
Other
- Has visceral metastases.
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.