Prospective Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer

NCT07117760 | Active Not Recruiting Phase 1

• 1 other identifier: FirstAHFujian-225Ac-LNC1011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. LNC1011 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 225Ac-labeled LNC1011 for treating patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Prostate-specific antigen 50 (PSA50) response

  PSA50 response is defined as the proportion of patients who have a more/equal 50% decrease in PSA from baseline, it will be calculated at 12, 24 and 48 months

  From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)

• Number of participants with Treatment Emergent Adverse Events

  The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

  From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  From date of enrollment until date of progression or date of death from any cause, whichever come first, assessed up to 50 months (estimated final OS analysis)

• Overall Survival (OS)

  From date of enrollment until date of death from any cause, assessed up to 50 months (estimated final OS analysis)

Other Outcomes (2)

• Time to Response (TTR)

  From date of enrollment till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)

• European Quality of Life ( EuroQoL) -5 Domain 5 Level Scale (EQ-5D-5L)

  From screening up till 30 day safety follow-up or week 48 of long term follow up for patient prematurely discontinued, assessed up to 50 months (estimated final OS analysis)

Study Arms (1)

225Ac-LNC1011

EXPERIMENTAL

Participant will receive 3.7 MBq (+/- 10%) 225Ac-LNC1011, once every 8-10 weeks for a planned 4 cycles

Drug: 225Ac-LNC1011; Drug: 68Ga-PSMA-11

Interventions

225Ac-LNC1011 DRUG

administered intravenously once every 8-10 weeks (1 cycle) for 4 cycles

225Ac-LNC1011

68Ga-PSMA-11 DRUG

Intravenous dose of approx. 150 MBq at screening and at time of centrally confirmed radiographic progressive disease

225Ac-LNC1011

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic Castration-Resistant Prostate Cancer (mCRPC) mCRPC refers to prostate cancer that progresses despite serum testosterone at castrate levels (\< 50 ng/dL or 1.7 nmol/L), meeting at least one of the following criteria:
• PSA \>1 ng/mL with two consecutive rises at least 1 week apart, each increase ≥50% above the nadir.
• Radiographic progression: Either two or more new bone lesions on bone scan, or soft tissue lesion progression as per RECIST 1.1 criteria. Progression based on symptoms alone is insufficient for mCRPC diagnosis and requires further evaluation.
• Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current Guidelines:
• Patients who have not received, refused, or progressed after receiving at least 1 but no more than 2 prior taxane-based therapies. The taxane regimen must have included exposure for at least 2 cycles. Patients who received only one taxane may be included if the investigator deems them unsuitable for a second taxane (e.g., due to frailty assessed by geriatric/comorbidity evaluation or intolerance).
• Patients who have progressed after receiving at least one novel androgen axis drug \[NAAD\] (e.g., abiraterone, enzalutamide).
• Ability to understand and voluntarily sign a written informed consent form (ICF), and willingness and ability to comply with trial procedures including examinations and follow-up.
• Age 18-90 years (inclusive).
• Expected survival \> 6 months.
• ECOG performance status ≤ 2.
• Presence of high-uptake lesions confirmed by 68Ga-PSMA-11 PET/CT imaging (positive defined as lesion uptake \>1.5 times the liver background).
• At least one measurable lesion per RECIST 1.1 criteria OR at least one bone metastasis per PCWG3 criteria.
• Adequate organ function (No blood products, growth factors, or albumin administered within 14 days prior to baseline lab tests):
• Bone Marrow Function: Neutrophil count ≥ 1.5 × 10⁹/L, White blood cell count ≥ 3.0 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 10 g/dL (≥ 100 g/L).
• Liver Function: Albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT or AST ≤ 3.0 × ULN (without liver metastases) or ≤ 5.0 × ULN (with liver metastases).

You may not qualify if:

• Inability to tolerate imaging procedures;
• Patients who have received systemic anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy; excluding endocrine therapy), investigational drugs, or device therapy within 4 weeks prior to dosing;
• Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months, or any External Beam Radiation Therapy (EBRT) within 2 months prior to the first dose;
• Patients with unresolved Grade 4 myelosuppression from prior anticancer therapy within 2 weeks, or Grade 3 myelosuppression requiring \>6 weeks for recovery;
• Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study;
• Use of blood products or albumin within 14 days before dosing to meet enrollment criteria;
• Brain metastasis at screening, except:
• Asymptomatic cases confined to supratentorial/cerebellar regions (no midbrain/pons/medulla/spinal cord involvement) without corticosteroid therapy and with lesions ≤1.5 cm;
• Symptomatic cases with treated and radiologically stable lesions (\>4 weeks);
• Other malignancies within 5 years (excluding cured localized cancers like basal/squamous cell skin carcinoma);
• Superscan on bone scintigraphy;
• Symptomatic or impending spinal cord compression;
• Prior EBRT involving extensive bone marrow (\>25%);
• Significant cardiac disease at screening, including:
• QTcF \>470 ms or long QT syndrome history;

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Weibing Miao, MD

  Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)