TheranosticTrials.org

Clinical Trial · NCT07381582

Safety, Tolerability and Preliminary Efficacy of 161Tb-LNC1011 (PSMA Radioligand) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Overview

This is a prospective, open-label, single-center, dose-escalation study using a standard 3+3 design to assess the safety, tolerability, biodistribution/dosimetry and preliminary efficacy of the albumin-binding PSMA radioligand 161Tb-LNC1011 in patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive intravenous 161Tb-LNC1011 starting at 50 mCi with planned dose-level escalations to 80, 130 and 200 mCi (±10%). Early dose levels (50 mCi) receive 1 cycle; later levels receive up to 4 cycles every 6 weeks based on safety and disease status. Primary endpoints include dose-limiting toxicities (DLTs), adverse events (AEs) graded by CTCAE v5.0, and determination of maximum tolerated dose (MTD). Secondary endpoints include organ/tumor absorbed doses, PSA responses (PSA50/PSA90), disease control, time to PSA progression and radiographic progression-free survival per PCWG3.

Sponsor

Peking Union Medical College Hospital

Phase

Early Phase 1

Contacts

Zhengguo Chen, MD (CONTACT)

86-13908119175

Zhaohui Zhu, MD (CONTACT)

13611093752@163.com

86-13611093752

ClinicalTrials.gov

NCT07381582

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

LNC1011

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Pathologically confirmed mCRPC per PCWG3.
  • Prior exposure to at least one novel androgen-axis drug (e.g., enzalutamide and/or abiraterone) or at least one taxane regimen, or intolerance/refusal to taxane chemotherapy.
  • Adequate organ function: ALT/AST ≤3× ULN; BUN/Cr ≤1.5× ULN; WBC ≥3.5×10\^9/L; PLT ≥100×10\^9/L; Hb ≥90 g/L.
  • ECOG 0-2; life expectancy ≥6 months.
  • Male, ≥18 years.
  • 68Ga-PSMA-11 PET/CT positive.

Exclusion

  • Inadequate contraception in patients of reproductive potential.
  • Unable to undergo SPECT/CT or to retain urine for 30 minutes.
  • Positive syphilis, HBV/HCV/HIV.
  • Psychiatric illness compromising compliance.
  • Autoimmune diseases (e.g., rheumatoid arthritis) requiring active management.
  • Immunodeficiency or recent use of immunosuppressants/immunoenhancers, recent vaccines.
  • Major trauma/surgery within 4 weeks prior to study treatment.
  • Known allergy to components of investigational product.
  • Active severe systemic or localized infection or other serious comorbidity.
  • Uncontrolled arrhythmias (incl. Afib), heart failure NYHA \> II, uncontrolled hypertension.
  • Any condition deemed unsuitable by the investigator.