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

Starting soon · Early Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07381582

Run by

Peking Union Medical College Hospital

People needed

15

Starts

2026-01-01

Expected to finish

2027-12-31

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, ≥18 years.
• Pathologically confirmed mCRPC per PCWG3.
• 68Ga-PSMA-11 PET/CT positive.
• 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.
• ECOG 0-2; life expectancy ≥6 months.
• 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.
• Signed informed consent and willingness to comply with study procedures.

You may not qualify if…

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

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• Mianyang Central Hospital — Mianyang, Sichuan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.