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[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

Phase 2 Study of Repeat-dose [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer

NCT05579184•FutureChem

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

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
+5 more criteria

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)
+9 more criteria

Locations (1)

The Catholic University of Korea, Seoul, St, Mary's Hospital, 222, Banpo-daero, Seocho-gu

Seoul, South Korea

Key Dates

Start Date

October 30, 2022

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

April 29, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer, mCRPC

Interventions

[177Lu]Ludotadipep

DRUG

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

NCT07103018

Metastatic Castration-resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients+3 more

View study

COMPLETEDPHASE1

Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT06377683

Metastatic Castration-resistant Prostate Cancer, mCRPC

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

Inclusion Criteria

Exclusion Criteria

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer

Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer