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OncoMatch/Clinical Trials/NCT06081686

Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

Is NCT06081686 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Phase I:[177Lu]Lu-XT033 and Phase II:[177Lu]Lu-XT033 for prostate cancer.

Phase 1/2RecruitingSinotau Pharmaceutical GroupNCT06081686Data as of May 2026

Treatment: Phase I:[177Lu]Lu-XT033 · Phase II:[177Lu]Lu-XT033This was a multicenter, open-label, phase I/II study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of \[177Lu\] Lu-XT033 injection in patients with metastatic prostate cancer, including a phase I study and a phase II extension study.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)

Must have received: taxane

Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens

Cannot have received: PSMA-targeted radioligand therapy

Previous PSMA-targeted radioligand therapy is not allowed

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

Exception: within 6 months of enrollment

Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation

Cannot have received: systemic anti-cancer therapy

Exception: within 28 days prior to day of enrollment

Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy) within 28 days prior to day of enrollment

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

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