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Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

ConditionmCRPC
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-85
SponsorShanghai Changzheng Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: LC-K76 + Tislelizumab + ADTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

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

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)

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) .

Time frame
From baseline to primary completion, which may take up to 24 to 48 weeks
3

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.

Time frame
From baseline to primary completion, which may take up to 24 to 48 weeks
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Changzheng Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: