OncoMatch/Clinical Trials/NCT07363486
Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
Is NCT07363486 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Radioligand therapy
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)
Demographics
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.
Frequently asked questions
Is NCT07363486 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, radionuclide therapy, external beam radiation therapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 high-uptake lesion on 68Ga-PSMA-11 PET/CT imaging is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 90 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages