A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

NCT07096128 | Recruiting Phase 1

• 1 other identifier: IIT-XTR021-1-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .

Conditions

mCRPC

Keywords

mCRPC; 177Lu; PSMA

Outcome Measures

Primary Outcomes (3)

• 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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

• Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection

  Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered \[177Lu\]Lu-PSMA-XT to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.

  From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months

Secondary Outcomes (8)

• Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)

  Through study completion, assessed up to 2 years.

• Prostate-specific Antigen 50 (PSA50) Response

  Through study completion, assessed up to 2 years.

• Time to PSA progression

  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.

Study Arms (1)

[177Lu]Lu-PSMA-XT

EXPERIMENTAL

\[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells

Drug: [177Lu]Lu-PSMA-XT

Interventions

[177Lu]Lu-PSMA-XT DRUG

\[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.

[177Lu]Lu-PSMA-XT

Eligibility Criteria

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

You may qualify if:

• Patients must have the ability to understand and sign an approved informed consent form (ICF).
• Patients must be \>= 18 and \<＝80 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must have a life expectancy \>6 months.
• Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
• Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
• Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• Patients must 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.
• Patients must have progressive mCRPC.
• Patients must 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

• Jinming Zhang: lead
• Sinotau Pharmaceutical Group: collaborator

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Mianyang Central Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The First Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Study Officials

• Jinming Zhang

  The First Medical Center, Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinming Zhang

CONTACT

(+86)010-66936108; Zhangjm301@163.com

Jinming Zhang

CONTACT

+861066936108; Zhangjm301@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 31, 2025
• Study Start: August 20, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)