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Recruiting Phase 1

A Study of SHR-4394 Injection in Subjects With Prostate Cancer

NCT06783829 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-01-22
Last updated
2025-02-27

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SHR4394

SHR4394: SHR4394

Study summary

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age range: 18-85 years old, male; 2. ECOG score for physical condition is 0-1 points; 3. Expected survival period ≥ 6 months; 4. Prostate adenocarcinoma confirmed by histological or cytological examination; 5. Patients with at least one metastasis lesion; 6. Disease progression on or after the most-recent prior regimen; 7. Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy; 8. Testosterone was at castration level; 9. Adequate organ function. Exclusion Criteria: 1. Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment; 2. Unresolved to CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy; 3. Meningeal metastasis history or clinical symptoms of central nervous system metastasis; 4. Uncontrollable tumor-related pain; 5. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms; 6. Other serious concomitant disease; 7. Previous or co-existing malignancies; 8. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394; 9. Active hepatitis B or active hepatitis C; 10. Other inappropriate situation considered by the investigator.

Primary outcome measure(s)

  • Dose-limiting toxicity (DLT) — 3 weeks.
  • Maximal tolerable dose (MTD) — 3 weeks.
  • Adverse events (AEs) — Screening up to study completion, an average of 1 year.
  • Recommended phase II dose (RP2D) — Screening up to study completion, an average of 1 year.

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06783829 on ClinicalTrials.gov ↗ ← All trials in China