mCRPCEarly Phase 1NCT07389187
Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Early Phase 1 study testing LC-K76, Tislelizumab and Standard Androgen Deprivation Therapy (ADT) in people with mCRPC, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- mCRPC
- What is being tested?
- LC-K76, Tislelizumab and Standard Androgen Deprivation Therapy (ADT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Life expectancy > 6 months.
- Adequate bone marrow, hepatic, and renal function.
- Willing to undergo biopsies before and during treatment
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Changzheng hospital
Shanghai, Shanghai Municipality, 201109
Shancheng Ren, PhD/MD, 86021-81886999, renshancheng@gmail.com
About this study
Official 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)
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
- Being tested
- LC-K76, Tislelizumab, Standard Androgen Deprivation Therapy (ADT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC-K76Dietary supplement
Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.
TislelizumabDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: LC-K76; Drug: Tislelizumab; Drug: Standard Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Secondary outcomes (4)
PSA Response Rate
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Disease control rate (DCR)
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) .
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Radiographic Progression-Free Survival (rPFS)
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.
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Time to First Skeletal-Related Event (SRE)
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.
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRPCStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Shancheng, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389187
- Sponsor's protocol ID
- LC-K76-201
- Status last verified
- Feb 2026
- First submitted
- 28 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07389187
- Acronym / sponsor ID
- LC-K76-201
- Conditions
- mCRPC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LC-K76 + Tislelizumab + ADT | Experimental | Dietary Supplement: LC-K76, Drug: Tislelizumab, Drug: Standard Androgen Deprivation Therapy (ADT)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (11 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC-K76Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner. | Dietary supplement | LC-K76 + Tislelizumab + ADT |
| TislelizumabIntravenous infusion, 200 mg every 3 weeks (Q3W). | Drug | LC-K76 + Tislelizumab + ADT |
| Standard Androgen Deprivation Therapy (ADT)Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix). | Drug | LC-K76 + Tislelizumab + ADT |
Primary outcome
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.
4 secondary outcomes
PSA Response Rate
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Disease control rate (DCR)
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Radiographic Progression-Free Survival (rPFS)
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Time to First Skeletal-Related Event (SRE)
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for mCRPC
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LC-K76, Tislelizumab and Standard Androgen Deprivation Therapy (ADT) in people with mCRPC, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ren, MD,PhD (86021-81886999, renshancheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From baseline to primary completion, which may take up to 24 to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.