Tests a radioactive drug, 161Tb-LNC1011, in advanced prostate cancer
Tests 161Tb-LNC1011 in men with prostate cancer that has spread.
Plain-language title generated from the registry record
Registry title: Safety, Tolerability and Preliminary Efficacy of 161Tb-LNC1011 (PSMA Radioligand) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Key facts
- Where
- Beijing and Mianyang, ChinaSee the 2 sites
- Phase
- Early phase 1
Where in China
- Peking Union Medical College HospitalBeijing, ChinaNo longer taking part
- Mianyang Central HospitalMianyang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07381582
- Record updated
- 2 February 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Open-label, Dose-Escalation, Single-Center Study to Evaluate the Safety, Biodistribution/Dosimetry and Preliminary Efficacy of 161Tb-LNC1011 in Patients With Metastatic Castration-Resistant Prostate Cancer
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.
Inclusion: 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.
Exclusion: Major trauma/surgery within 4 weeks prior to study treatment; Immunodeficiency or recent use of immunosuppressants/immunoenhancers, recent vaccines; Known allergy to components of investigational product; Active severe systemic or localized infection or other serious comorbidity; Autoimmune diseases (e.g., rheumatoid arthritis) requiring active management; Uncontrolled arrhythmias (incl. Afib), heart failure NYHA > II, uncontrolled hypertension; Positive syphilis, HBV/HCV/HIV; Psychiatric illness compromising compliance; Any condition deemed unsuitable by the investigator; Inadequate contraception in patients of reproductive potential; Unable to undergo SPECT/CT or to retain urine for 30 minutes.