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Metastatic Castration-resistant Prostate CancerPhase 1NCT04509557

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

A Phase 1 study testing [177Lu]Ludotadipep in people with Metastatic Castration-resistant Prostate Cancer, run by FutureChem at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, men only
What is being tested?
[177Lu]Ludotadipep
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
14 Oct 2020to 30 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul

Other trials in South Korea

About this study

Official title: [177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer: Phase I Clinical Trial.

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.

Read the detailed description

[18F]PSMA PET/CT is conducted at the 2nd screening and only PSMA PET/CT positive patients can be enrolled (PSMA RADS 4 or more).

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).

Being tested
[177Lu]Ludotadipep
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [177Lu]LudotadipepDrug

    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.

Study groups in NCT04509557
Study groupRoleWhat they receive
50mCiExperimentalUsing 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.
Receives: Drug: [177Lu]Ludotadipep
75mCiExperimentalUsing 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.
Receives: Drug: [177Lu]Ludotadipep
100mCiExperimentalUsing 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.
Receives: Drug: [177Lu]Ludotadipep
125mCiExperimentalUsing 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.
Receives: Drug: [177Lu]Ludotadipep
150mCiExperimentalUsing 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.
Receives: Drug: [177Lu]Ludotadipep

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. PSA level assessment

    Comparative assessment of the PSA level before and after administration of [177Lu]Ludotadipep

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

  2. Radiological assessment

    Comparative assessment of the locations and the quantitative change of a lesion on [18F]PSMA PET/CT before and after administration of [177Lu]Ludotadipep, and assessment of the treatment response by comparing the intake of the target lesion from an imaging test at each time point.

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

  3. Biodistribution

    Assessment of the absorption (uptake) into the blood, lungs, liver, spleen, pancreas, kidneys, muscle, stomach, and tumor based on the level obtained from SPECT/CT imaging at 2 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days) and additionally perform planar scan at visit 4.

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

  4. Whole-body absorbed dose

    Calculation of the whole-body absorbed dose by evaluating the absorbed dose into the adrenals, brain, gallbladder, intestine, stomach, heart, kidney, liver, muscle, lungs, pancreas, red marrow, skin, spleen, testes, thymus, thyroid, and urinary bladder.

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

  5. Safety assessment by baseline symptoms

    Assessment of adverse events occured from screening (Day -31) and 2nd screening(Day -31 ~ -20) before IP administration.

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

  6. Safety assessment by adverse events

    Assessment of adverse events occured from IP administration (visit 3,Day 0~3) until visit10 (Day87)

    Measured: visit 3(Day 0 ~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  7. Number of participants with abnormal signs and symptom as assessed through physical examination

    Number of participants with abnormal signs and symptom as assessed through physical examination from screening(Day -31 ~ -20) to visit10 (Day87)

    Measured: Screening(Day -31 ~ -20), 2nd screening(Day -19 ~ -1), visit 3(Day 0~3), visit4 (Day 10), visit5 (Day 17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  8. Systolic and diastolic blood pressure (mm Hg)

    Assessment of masured value using systolic and diastolic blood pressure (mm Hg) from screening(Day -31 ~ -20) to visit10 (Day87)

    Measured: Screening(Day -31 ~ -20), 2nd screening(Day -19 ~ -1), visit 3(Day 0~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  9. Body temperature (degrees Celsius)

    Assessment of masured value using body temperature (degrees Celsius) from screening(Day -31 ~ -20) to visit10 (Day87)

    Measured: Screening(Day -31 ~ -20), 2nd screening(Day -19 ~ -1), visit 3(Day 0~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  10. Pulse rate (beats per minute)

    Assessment of masured value using pulse rate (beats per minute) from screening(Day -31 ~ -20) to visit10 (Day87)

    Measured: Screening(Day -31 ~ -20), 2nd screening(Day -19 ~ -1), visit 3(Day 0~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  11. Number of participants with abnormal hematology values

    Number of participants with abnormal hematology values ( WBC, WBC differential, Hemoglobin, Hematocrit, RBC, Platelet, free lutetium -at 3 minutes, 15 minutes, 30 minutes, 60 minutes, 180 minutes, 24 hours, 48 hours, and 72 hours after IP administration) from screening(Day -31 ~ -20) to visit10 (Day87) except 2nd screening(Day -19 ~ -1).

    Measured: Screening(Day -31 ~ -20), visit 3(Day 0~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  12. Number of participants with abnormal chemistry values

    Assessment of masured value using chemistry( free PSA, glucose, Total bilirubin, AST/ALT, Alkaline phosphatase, BUN/ Creatinine, Sodium, Potassium, Chloride, CA, Phosphorus, Total Protein, Albumin) from screening(Day -31 ~ -20) to visit10 (Day87) except 2nd screening(Day -19 ~ -1).

    Measured: Screening(Day -31 ~ -20), visit 3(Day 0~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

  13. Number of participants with abnormal urinalysis values

    Assessment of masured value using urinalysis (Specific Gravity, Protein, pH, Glucose, Occult Blood, Ketone) from screening(Day -31 ~ -20) to visit10 (Day87) except 2nd screening(Day -19 ~ -1).

    Measured: Screening(Day -31 ~ -20), visit 3(Day 0~3), visit4 (Day10), visit5 (Day17), visit6(Day24), visit7(Day31), visit8(Day45), visit9(Day59), visit10 (Day87)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start14 Oct 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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).
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04509557
Sponsor's protocol ID
FC705-1
Status last verified
Oct 2022
First submitted
7 Jul 2020
Last updated
20 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16341066

  • 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.

    PubMed 23590171

  • 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.

    PubMed 26681984

  • 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.

    PubMed 26902337

  • 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.

    PubMed 26728408

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [177Lu]Ludotadipep in people with Metastatic Castration-resistant Prostate Cancer, run by FutureChem at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04509557, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

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