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

NCT07389187 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-05

No results posted yet for this study

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. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.

Conditions

Interventions

DIETARY_SUPPLEMENT

LC-K76

Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.

DRUG

Tislelizumab

Intravenous infusion, 200 mg every 3 weeks (Q3W).

DRUG

Standard Androgen Deprivation Therapy (ADT)

Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-12-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389187 on ClinicalTrials.gov