[177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer.

NCT04509557 | Completed Phase 1

• 1 other identifier: FC705-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the stability and efficacy after administration of \[177Lu\]Ludotadipep in patients with metastatic castration resistant prostate cancer (mCRPC), with dose-escalation applied to determine the appropriate dose.

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  Dose-limiting toxicity is defined as CTCAE grade 4 thrombocytopenia (platelet count \<25x109/L), grade 4 neutropenia (absolute neutrophil count (ANC) \< 0.5 x 109), grade 3 febrile neutropenia (ANC \<1000/mm3 and temperature \>38.3℃ on at least 1 occasion or temperature ≥38℃ persisting for 1 hr), and other grade 3 or 4 non-hematological toxicity resulting from \[177Lu\]Ludotadipep, persisting for 5 days or more.

  From date of randomization (IP administration (0h, visit3, Day 0 ~ 3)) until the date of grade 4 neutropenia, grade 3 febrile neutropenia, other grade 3 or 4 non-hematological toxicity resulting from [177Lu]Ludotadipep, persisting for 5 days or more.

Secondary Outcomes (13)

• PSA level assessment

  screening(Day -31 ~ -20), , visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

• Radiological assessment

  2nd screeing(Day -19 ~ -1 ), visit7(Day31), visit9(Day59)

• Biodistribution

  2 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days) at visit3 (Day 0~3), visit 4(Day10)

• Whole-body absorbed dose

  2 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days) at visit3(Day 0~3)

• Safety assessment by baseline symptoms

  Screening(Day -31 ~ -20), 2nd screening(Day -19 ~ -1)

Study Arms (5)

50mCi

EXPERIMENTAL

Using a drug product for which dose is determined (50±5 mCi dose), dilute with 0.9% NaCl 5 mL and slowly i.v. inject over 10 minutes, with 500 mL of 0.9% NaCl slowly administered for hydration over approximately 90 minutes from 30 minutes before treatment to 60 minutes after treatment.

Drug: [177Lu]Ludotadipep

75mCi

EXPERIMENTAL

Using a drug product for which dose is determined (75±8 mCi dose), dilute with 0.9% NaCl 5 mL and slowly i.v. inject over 10 minutes, with 500 mL of 0.9% NaCl slowly administered for hydration over approximately 90 minutes from 30 minutes before treatment to 60 minutes after treatment.

Drug: [177Lu]Ludotadipep

100mCi

EXPERIMENTAL

Using a drug product for which dose is determined (100±10 mCi dose), dilute with 0.9% NaCl 5 mL and slowly i.v. inject over 10 minutes, with 500 mL of 0.9% NaCl slowly administered for hydration over approximately 90 minutes from 30 minutes before treatment to 60 minutes after treatment.

Drug: [177Lu]Ludotadipep

125mCi

EXPERIMENTAL

Using a drug product for which dose is determined (125±13 mCi dose), dilute with 0.9% NaCl 5 mL and slowly i.v. inject over 10 minutes, with 500 mL of 0.9% NaCl slowly administered for hydration over approximately 90 minutes from 30 minutes before treatment to 60 minutes after treatment.

Drug: [177Lu]Ludotadipep

150mCi

EXPERIMENTAL

Using a drug product for which dose is determined (150±15 mCi dose), dilute with 0.9% NaCl 5 mL and slowly i.v. inject over 10 minutes, with 500 mL of 0.9% NaCl slowly administered for hydration over approximately 90 minutes from 30 minutes before treatment to 60 minutes after treatment.

Drug: [177Lu]Ludotadipep

Interventions

[177Lu]Ludotadipep DRUG

Dose is sequentially elevated starting from a low dose to a high dose (50±5 mCi, 75±8 mCi, 100±10 mCi, 125±13 mCi, 150±15 mCi). If DLT is observed in 2 or less of 6 subjects at each level, advance to the next step. If DLT is observed in 3 or more participants, no further subject will participate in the study at the relevant dose. Appropriateness of the dose elevation is evaluated 8-9 weeks after drug administration.

100mCi; 125mCi; 150mCi; 50mCi; 75mCi

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Male patients aged 20 years or older.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Among prostate cancer patients with blood testosterone ≤50ng/dL, mCRPC patients showing radiological progression after standard taxene-based anticancer treatment and 2nd generation hormone agent (abiraterone, enzalutamed, or both)) treatment or patients who are not eligible for such standard medical treatment at the discretion of an investigator or patients who refuse such standard treatment
• Patients who are positive on the \[18F\]PSMA PET/CT imaging
• Subjects who were fully informed by an investigator of the study objectives, details, and characteristics of the study drug prior to study enrollment, and had an informed consent form signed by the subject or caretaker or legally acceptable representative
• Male patients aged 20 years or older
• Subjects who are sexually active and have a female partner of childbearing potential should meet the followings
• Subjects should consent to practice contraception by continuously using a male condom from screening, throughout the study, and for at least 6 months after the last dose of the study drug
• Subjects should never donate sperms from screening, throughout the study, and for at least 6 months after the last dose of the study drug
• Subjects with a partner who is a woman of childbearing potential (including a pregnant or breastfeeding mother) should consent to maintain sexual abstinence or practice double contraception throughout the study \* Double contraception: Corresponding to 2 or more of the followings - use of a condom, use of a non-hormonal intrauterine device, use of a diaphragm, use of a cervical cap, a sexual partner who has been vasectomized at least 3 months (as of the first screening visit) or a sexual partner medically diagnosed to be sterile
• ECOG \_ Performance score ≤2
• Life expectancy ≥6 months

You may not qualify if:

• Subjects determined by an investigator to have a serious medical condition making study conduct difficult
• Subjects corresponding to the following conditions 1) Glomerular filtration rate ≤40 ml/min, 2) hemoglobin level ≤10.0 g/dL, 3) white cell count ≤4.0 × 109/L, 4) platelet count ≤100 × 109/L, 5) total bilirubin level ≥1.5 x upper normal limit, 6) serum albumin level ≤3.0 g/dL, 7) active ischemic heart disease or heart failure (New York Heart Association Classification III-IV), 8) uncontrolled diabetes/hypertension, 9) hyperkalemia \>6.0 mmol/L
• Vulnerable subjects (the investigator involved in the study or his/her family, research staff or students of the investigator involved in the study)
• Patients with a persistent malignancy other than the prostate cancer
• Patients who participated in a therapeutic clinical trial within the past 30 days and administered an investigational product other than standard treatment
• Patients are excluded if treatment other than the treatment provided in this study is determined more appropriate as determined by the investigator based on the patient and disease characteristics

Sponsors & Collaborators

• FutureChem: lead

Study Sites (1)

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

Seoul, South Korea

Location

Related Publications (5)

• Zhou J, Neale JH, Pomper MG, Kozikowski AP. NAAG peptidase inhibitors and their potential for diagnosis and therapy. Nat Rev Drug Discov. 2005 Dec;4(12):1015-26. doi: 10.1038/nrd1903.

  PMID: 16341066 BACKGROUND

• Mease RC, Foss CA, Pomper MG. PET imaging in prostate cancer: focus on prostate-specific membrane antigen. Curr Top Med Chem. 2013;13(8):951-62. doi: 10.2174/1568026611313080008.

  PMID: 23590171 BACKGROUND

• Lutje S, Heskamp S, Cornelissen AS, Poeppel TD, van den Broek SA, Rosenbaum-Krumme S, Bockisch A, Gotthardt M, Rijpkema M, Boerman OC. PSMA Ligands for Radionuclide Imaging and Therapy of Prostate Cancer: Clinical Status. Theranostics. 2015 Oct 18;5(12):1388-401. doi: 10.7150/thno.13348. eCollection 2015.

  PMID: 26681984 BACKGROUND

• Maurer T, Eiber M, Schwaiger M, Gschwend JE. Current use of PSMA-PET in prostate cancer management. Nat Rev Urol. 2016 Apr;13(4):226-35. doi: 10.1038/nrurol.2016.26. Epub 2016 Feb 23.

  PMID: 26902337 BACKGROUND

• Haberkorn U, Eder M, Kopka K, Babich JW, Eisenhut M. New Strategies in Prostate Cancer: Prostate-Specific Membrane Antigen (PSMA) Ligands for Diagnosis and Therapy. Clin Cancer Res. 2016 Jan 1;22(1):9-15. doi: 10.1158/1078-0432.CCR-15-0820.

  PMID: 26728408 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ji Youl Lee

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose is administered by differentiated into 5 groups (6 subjects each) and sequentially elevated starting from a low dose to a high dose (50±5 mCi, 75±8 mCi, 100±10 mCi, 125±13 mCi, 150±15 mCi).

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 12, 2020
• Study Start: October 14, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)