Prospective Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Pā¦ (NCT07117760) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
Prospective Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
China16 participantsStarted 2025-04-22
Plain-language 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).
Who can participate
Age range18 Years ā 90 Years
SexMALE
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Inclusion criteria
ā. 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:
ā. Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current Guidelines:
ā. 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.
ā. Age 18-90 years (inclusive).
ā. Expected survival \> 6 months.
ā. ECOG performance status ā¤ 2.
ā. Presence of high-uptake lesions confirmed by 68Ga-PSMA-11 PET/CT imaging (positive defined as lesion uptake \>1.5 times the liver background).
ā. At least one measurable lesion per RECIST 1.1 criteria OR at least one bone metastasis per PCWG3 criteria.
Exclusion criteria
ā. Inability to tolerate imaging procedures;
ā. 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;
ā. 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;
What they're measuring
1
Prostate-specific antigen 50 (PSA50) response
Timeframe: From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)
2
Number of participants with Treatment Emergent Adverse Events
Timeframe: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
Trial details
NCT IDNCT07117760
SponsorFirst Affiliated Hospital of Fujian Medical University
ā. Patients with unresolved Grade 4 myelosuppression from prior anticancer therapy within 2 weeks, or Grade 3 myelosuppression requiring \>6 weeks for recovery;
ā. Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study;
ā. Use of blood products or albumin within 14 days before dosing to meet enrollment criteria;
ā. Brain metastasis at screening, except:
ā. Other malignancies within 5 years (excluding cured localized cancers like basal/squamous cell skin carcinoma);