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OncoMatch/Clinical Trials/NCT07117760

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

Is NCT07117760 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including 225Ac-LNC1011 and 68Ga-PSMA-11 for prostate cancer.

Phase 1/2RecruitingFirst Affiliated Hospital of Fujian Medical UniversityNCT07117760Data as of May 2026

Treatment: 225Ac-LNC1011 · 68Ga-PSMA-11PSMA 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).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 2 prior lines
Min 1 prior line

Must have received: taxane

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).

Must have received: novel androgen axis drug (abiraterone, enzalutamide)

Patients who have progressed after receiving at least one novel androgen axis drug [NAAD] (e.g., abiraterone, enzalutamide).

Cannot have received: systemic anticancer therapy

Exception: endocrine therapy

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

Cannot have received: radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177)

Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months

Cannot have received: external beam radiation therapy

any External Beam Radiation Therapy (EBRT) within 2 months prior to the first dose

Cannot have received: cytotoxic chemotherapy

Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study

Cannot have received: antitumor immunotherapy

Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study

Cannot have received: radioligand therapy

Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study

Cannot have received: blood products or albumin

Use of blood products or albumin within 14 days before dosing to meet enrollment criteria

Lab requirements

Blood counts

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)

Kidney function

Serum creatinine ≤ 1.5 × ULN

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)

Cardiac function

QTcF ≤ 470 ms, no long QT syndrome history, no myocardial infarction, angina, or CABG within 6 months deemed ineligible by investigators

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). Renal Function: Serum creatinine ≤ 1.5 × ULN. Coagulation: INR ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 2 × ULN (for patients not on anticoagulation or on stable-dose anticoagulation).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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