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

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

Treatments tested in this trial

  • LC-K76
  • Tislelizumab
  • Standard Androgen Deprivation Therapy (ADT)

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators