OncoMatch/Clinical Trials/NCT07363486
Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
Is NCT07363486 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies 225Ac-LNC1011 for prostate cancer.
Treatment: 225Ac-LNC1011 — PSMA is an ideal target for the precise diagnosis and treatment of prostate cancer. LNC1011 is a novel albumin-binding PSMA-targeted compound. This study aims to investigate the safety and efficacy of different doses of 225Ac-labeled LNC1011 in the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and to explore the optimal therapeutic dose.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 high-uptake lesion on 68Ga-PSMA-11 PET/CT imaging (lesion uptake >1.5 times the liver background)
Presence of high-uptake lesions confirmed by 68Ga-PSMA-11 PET/CT imaging (positive defined as lesion uptake >1.5 times the liver background)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: taxane
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).
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: excluding 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: external beam radiation therapy
Prior EBRT involving extensive bone marrow (>25%)
Lab requirements
Blood counts
neutrophil count ≥ 1.5 × 10#/l, white blood cell count ≥ 3.0 × 10#/l, platelet count ≥ 100 × 10#/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 or long qt syndrome history; myocardial infarction, angina, or cabg within 6 months deemed ineligible by investigators
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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