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

NCT ID: NCT06081686

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2025-12-31

Brief Summary

This 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.

Detailed Description

The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period.

In phase I,Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of [177Lu] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval for a total of 4 doses.In phase II,Subjects who met the inclusion and exclusion criteria were treated with [177Lu] Lu-XT033 injection at the recommended phase II dose（RP2D）.After Cycle 4 treatment and prior to Cycle 5 treatment, the investigator assessed the following criteria to determine whether:

The patient showed evidence of response (i.e. radiological, PSA, clinical benefit)

The patient had signs of residual disease on CT with contrast/MRI or bone scan

The patient had shown good tolerance to the [177Lu] Lu-XT033 Injection

If the patient met all of the criteria above and agreed to continue with additional treatment of [177Lu] Lu-XT033, the Investigator could administer 2 additional cycles. A maximum of 6 cycles of [177Lu] Lu-XT033 as allowed.

All subjects continued to undergo safety, tolerability, and efficacy assessments until the study-specified visit occurred or the subject was lost to follow-up or death whichever came first.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I:[177Lu]Lu-XT033 Injection

During dose verification phase,Patients received \[177Lu\]Lu-XT033 Injection 1.11Gbq（30mCi）/1.85Gbq（50mCi）intravenously every 8 weeks (+/- 1 week) for a maximum of 6 cycles.

Group Type: EXPERIMENTAL

Phase I:[177Lu]Lu-XT033 Injection

Intervention Type: DRUG

Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of \[177Lu\] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval .

Phase II:[177Lu]Lu-XT033 Injection

During dose expansion phase,patients received \[177Lu\]Lu-XT033 Injection at R2PD based on phase I.

Group Type: EXPERIMENTAL

Phase II:[177Lu]Lu-XT033 Injection

Intervention Type: DRUG

Patients received \[177Lu\]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles.

Interventions

Phase I:[177Lu]Lu-XT033 Injection

Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of \[177Lu\] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval .

Intervention Type: DRUG

Phase II:[177Lu]Lu-XT033 Injection

Patients received \[177Lu\]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must have the ability to understand and sign an approved informed consent form (ICF).

2. Patients must be >= 18 and <＝80 years of age.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Patients must have a life expectancy >6 months.

5. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.

6. Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。

7. Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).

8. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens.

9. Patients must have progressive mCRPC.

10. Patients must have adequate organ function。

11. 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.

Exclusion Criteria

1. 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.

2. Known other malignancies.

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

4. Known hypersensitivity to the components of the study therapy or its analogs.

5. A superscan as seen in the baseline bone scan.

6. Patients with a history of Central Nervous System (CNS) metastases.

7. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dingwei Ye

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Zhi Yang

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Shan Zhang

Role: CONTACT

zhangshan@sinotau.com

010-52805710

Other Identifiers

XT-XTR010-1-01

Identifier Type: -

Identifier Source: org_study_id