NCT07381582Not yet recruitingEarly phase 1
Safety, Tolerability and Preliminary Efficacy of 161Tb-LNC1011 (PSMA Radioligand) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 23 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07381582
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 15
- From 1 Jan 2026 to the primary completion date, 31 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Inadequate contraception in patients of reproductive potential.
- Unable to undergo SPECT/CT or to retain urine for 30 minutes.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Mianyang Central Hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.