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Trial Title:
Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
NCT ID:
NCT06081686
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
[177Lu]Lu-XT033 Injection
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Phase I:[177Lu]Lu-XT033 Injection
Description:
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 .
Arm group label:
Phase I:[177Lu]Lu-XT033 Injection
Intervention type:
Drug
Intervention name:
Phase II:[177Lu]Lu-XT033 Injection
Description:
Patients received [177Lu]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6
cycles.
Arm group label:
Phase II:[177Lu]Lu-XT033 Injection
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100042
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Start date:
September 13, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Sinotau Pharmaceutical Group
Agency class:
Industry
Source:
Sinotau Pharmaceutical Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081686
