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Trial Title:
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2
NCT ID:
NCT05579184
Condition:
Metastatic Castration-resistant Prostate Cancer, mCRPC
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[177Lu]Ludotadipep
Description:
Patients will receive 100 mCi of [177Lu]Ludotadipep every 8 [±1] weeks (up to 6 times)
- Test article code/name: [177Lu]Ludotadipep
- Administration route: intravenous injection
- Total dose strength: 4 to 6 x 3.7 GBq
- Dosage form: solution for injection
Arm group label:
[177Lu]Ludotadipep 100 mCi
Summary:
100 mCi of [177Lu]Ludotadipep, the dose determined in the phase 1 clinical trial
(FC705-1), was administered repeatedly up to 6 times at intervals of 8 weeks (±2 weeks)
to patients with metastatic castration resistant prostate cancer (mCRPC) in order to
assess the safety and efficacy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult male over the age of 19 as of the date of written consent
2. Adenocarcinoma confirmed by histopathology or cytology
3. Those who have been confirmed with at least two metastases in the soft tissue
lesions or bone lesions based on the PCWG3 modified RECIST v1.1 criterion for
prostate adenocarcinoma, or those who experience pain due to radiologically apparent
disease progression
4. Those with castration resistance with a blood testosterone level of 50 ng/dL or less
at the time of screening and those who meet one or more of the criteria below
- Prostate cancer patients with resistance against imaging-based progression of
metastatic castration even after at least 4 weeks of imaging-based progression
of standard medical treatment using one or more second-generation hormonal
agents (e.g., enzalutamide, abiraterone) are administered in combination with
standard taxene-based chemotherapy (e.g., docetaxel).
- In cases where the patient is judged unsuitable by the investigator for
the standard medical treatment specified above
- In cases where the patient himself/herself refuses the standard
medical treatment specified above
5. Those that exhibit lesions of 4 or higher PSMA reporting and data system (P-RADS) in
the [18F] PSMA PET/CT imaging at the time of screening
6. Those that exhibit higher or wider uptake of the lesion in [18F] PSMA PET/CT imaging
than [18F] FDG PET taken at the time of screening as judged by the investigator
7. Those who exhibit an ECOG performance score of level 2 or less at the time of
screening and with an expected survival period of at least 6 months
8. Subjects having active sexual activities with a fertile female spouse must satisfy
the following:
- If the spouse is a fertile woman (including pregnant and lactating women), the
subject must consent to maintain abstinence or to use double contraception*
from the time of screening and throughout the entire clinical trial period and
at least 6 months after the administration of the last investigational drug.
- Sperm of the subject must not be donated during the entire clinical trial
period from the time of screening and for at least 6 months after the
administration of the last investigational drug.
- Double contraception: If applicable to at least two of the following: the
use of condoms, non-hormonal intrauterine device, diaphragm, cervical cap,
if it has been more than 3 months since the male spouse had a vasectomy
(at the time of initial screening visit), or the spouse is medically
diagnosed with infertility
9. Those who have fully understood the purpose, details, and characteristics of the
investigational drug from the investigator before enrolling in the clinical trial
and signed the informed consent form in person or by guardian or legal
representative
Exclusion Criteria:
1. Those who are judged to have abnormalities in bone marrow, liver, or kidney function
as they are in accordance with the results of laboratory tests that satisfy at least
one of the following criteria at the time of screening:
- If ANC is below 1.5 x 109/L
- If Hemoglobin is below 9.0 g/dL
- If the platelet count is below 100 x 109/L
- If total bilirubin exceeds 1.5 times the normal value,
- If serum albumin is below 2.5 g/dL
- If the glomerular filtration rate (eGFR) is below 50
mL/min
2. Those with one or more of the following diseases at the time of screening
- Those who correspond to Classification III-IV under the New York Heart
Association (NYHA) classification of patients with severe heart failure
- Patients with uncontrolled hypertension (SBP > 160 mm Hg or DBP > 90 mm
Hg)
- Patients with uncontrolled diabetes (HbA1c > 7.0% or fasting blood
sugar > 160 mg/dL)
3. Those with a history of prostate cancer or solid cancer other than radical
metastasis limited to bone or soft tissue with basis on prostate cancer or blood
cancer including lymphoma within 3 years from the time of screening (However,
non-melanoma skin cancer, superficial bladder cancer, thyroid cancer, and
intraepithelial carcinoma (carcinoma in situ) that do not require continued
treatment as they are treated appropriately and remain disease-free within 2 years
from the time of screening)
4. Those who have received radiopharmaceutical treatment or radiotherapy for the target
lesion of metastatic prostatic carcinoma within 12 weeks from the time of screening
5. Those with active infection of HIV, HBV, HCV, or VDRL at the time of screening, or
those with other uncontrolled active infectious diseases with proteinuria of > 1.0
in protein under the urine protein vs. creatinine ratio
6. Those suffering from one or more disease of the following: Immunosuppressive status
(including nephrectomy, hematopoietic stem cell transplantation) and autoimmune
disease patients (including severe myasthenia, Hashimoto thyroiditis, rheumatoid
arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) at the
time of screening
7. Those who had participated in a therapeutic clinical trial within 30 days of
screening and had been administered or applied with other investigational products
or investigational devices.
8. Those with potential hypersensitivity reaction to this investigational product
[177Lu] ludotadipep
9. Those with an anamnesis of clinically significant mental illness, alcohol abuse,
etc.
10. Those who are judged unsuitable by the investigator to participate in this clinical
trial for other miscellaneous reasons or who are judged incompatible with the
administration requirements
Gender:
Male
Gender based:
Yes
Gender description:
Male patients aged 19 years or older
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Catholic University of Korea, Seoul, St, Mary's Hospital, 222, Banpo-daero, Seocho-gu
Address:
City:
Seoul
Country:
Korea, Republic of
Start date:
October 30, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
FutureChem
Agency class:
Industry
Source:
FutureChem
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05579184