A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

NCT07135102 | Recruiting Phase 1

• 1 other identifier: SDZLEC2024-365-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC

Conditions

Metastatic Castration-Resistant Prostate Cancer Patients

Outcome Measures

Primary Outcomes (2)

• Treatment emergent adverse events

  To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.

  Through study completion, assessed up to 2 years

• Dose-limiting toxicity（DLT）

  Incidence and severity of dose-limiting toxicities.

  Through study completion, assessed up to 2 years

Secondary Outcomes (5)

• Prostate-specific Antigen 50 (PSA50) Response

  Through study completion, assessed up to 2 years.

• Radiographic Progression-free Survival (rPFS)

  Through study completion, assessed up to 2 years.

• Overall Response Rate (ORR)

  Through study completion, assessed up to 2 years.

• Duration of Response (DOR)

  Through study completion, assessed up to 2 years.

• Disease Control Rate (DCR)

  Through study completion, assessed up to 2 years.

Study Arms (1)

225Ac-PSMA-XT treatment

EXPERIMENTAL

Drug: 225Ac-PSMA-XT

Interventions

225Ac-PSMA-XT DRUG

Patients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose.

225Ac-PSMA-XT treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have the ability to understand and sign an approved informed consent form (ICF).
• \>= 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• have a life expectancy \>6 months.
• have histological, pathological, and/or cytological confirmation of prostate cancer.
• PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
• have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
• progressive mCRPC.
• have adequate organ function。
• Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.

You may not qualify if:

• 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. Previous PSMA-targeted radioligand therapy is not allowed.
• Known other malignancies.
• Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
• Known hypersensitivity to the components of the study therapy or its analogs.
• A superscan as seen in the baseline bone scan.
• Patients with a history of Central Nervous System (CNS) metastases.
• Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

Sponsors & Collaborators

• Xiaorong Sun: lead

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 100023, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

CN (1)