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Metastatic Castration-resistant Prostate Cancer, mCRPCPhase 1NCT06237491

The Safety and Dosimetry Study of 177Lu-LNC1003 Injection

A Phase 1 study testing 177Lu-LNC1003 Injection group 1, 177Lu-LNC1003 Injection group 2 and 177Lu-LNC1003 Injection group 3 in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by Yantai LNC Biotechnology Singapore PTE. LTD..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC. In the clinical development, we aim to demonstrate the following: 1. Determination of the therapeutic dose(s) to be used in the expansion phase. 2. Read more about this study

Who is it for?
Ages 21 years and older, men only
What is being tested?
177Lu-LNC1003 Injection group 1, 177Lu-LNC1003 Injection group 2 and 177Lu-LNC1003 Injection group 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
7 May 2025to 17 Dec 2025
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 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients or authorized guardians must have the ability to understand and sign an approved informed consent form (ICF).
  • Patients must have the ability to understand and comply with all protocol requirements.
  • Patients must be aged 21 years or older.
  • Patients must have histological, pathological, and/or cytological confirmation of PC that is refractory to or has progressed following prior treatments.
  • Patients must have ≥ 1 metastatic lesion present on baseline and documented progressive mCRPC based on the Prostate Cancer Working Group 3 (PCWG3) criteria; patients must fill at least one of the following criteria:
  • PSA progression
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  • Objective radiographic progression in soft tissue
  • New bone lesions
  • Patients must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
  • Patients must have received treatment with at least one prior novel androgen receptor pathway inhibitor (such as enzalutamide, apalutamide, and/or abiraterone).
  • Patients must have been deemed not suitable for chemotherapy, i.e., the patient refused chemotherapy or was judged unsuitable for chemotherapy by the doctor. Alternatively, patients may have been previously treated with at least one, but no more than two previous taxane regimens, or have been offered, but declined, or been ineligible for taxane-based chemotherapy. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only one taxane regimen, the patient is eligible if:
  • The patient\'s physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation, intolerance, etc.).
  • Patients must have at least 1 measurable lesion as defined by Response Criteria in Solid Tumors (RECIST) version 1.1.
  • Patients must be 68Ga-PSMA-11 PET/CT scan positive.
  • Patients must have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Patients must have an adequate organ function, in the absence of clinical intervention within 28 days before the administration of the 177Lu-LNC1003, as defined by:
  • Hemoglobin (Hb) > 9.0g/dL White blood cell (WBC) count ≥ 3 x 109/L or absolute neutrophil count (ANC) >1.5 x 109/L Platelets ≥ 100 x 109/L International normalized ratio (INR) <1.5 for patients that are not on warfarin Prothrombin time (PTT) < 2 x ULN Total bilirubin <1.5 x ULN Serum albumin >3.0 g/dL Alanine aminotransferase (ALT) <3 x ULN, or<5 x ULN if deemed related to liver metastases from solid tumor Aspartate aminotransferase (AST) <3 x ULN, or<5 x ULN if deemed related to liver metastases from solid tumor Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
  • All other toxicity parameters, except for alopecia, must be NCI-CTCAE v.5.0 Grade 0 or 1.
  • Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow 1 of the following methods of contraception consistently, starting from screening, during the study and for at least 14 weeks after the last dose of 177Lu-LNC1003 Injection:
  • Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); Agree to use a male condom and have their partner use a contraceptive method with a failure rate of \&lt; 1% per year as described below when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.
  • Participants must agree to refrain from donating sperm starting from Screening, during the study and for at least 14 weeks after the last dose of 177Lu-LNC1003 Injection.
  • Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile vaginal intercourse; or use a male condom during each episode of penile penetration during the study.

Who cannot join

  • Other identified malignancies within 5 years in addition to radically treated locally curable malignant tumors, such as basal or squamous cell skin cancer, superficial bladder cancer.
  • Previous treatment with any of the following within 6 months before enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation, 177Lu-PSMA-617 (Pluvicto) and any investigational beta-emitting radiotherapeutics.
  • Any systemic anti-cancer therapy (e.g. PSMA-targeted radioligand therapy, chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of enrollment
  • Any investigational agents within 28 days of enrollment
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
  • Transfusion for the sole purpose of making a subject eligible for study inclusion
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-LNC1003 as assessed from medical records
  • Participants who have not fully recovered from major surgery or significant traumatic injury prior to the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug
  • Life expectancy \&lt; 6 months as assessed by the treating physician
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
  • A superscan; i.e., very high ratio of bone to background uptake due to high osteoblastic activity, as seen in the baseline Tc-99m diphosphonate bone scan.
  • Clinically significant abnormalities on electrocardiogram (ECG) at screening including QTcF \&gt; 470 ms, and subjects who cannot tolerate high volume load.
  • Active and clinically significant bacterial, fungal, or viral infections, including hepatitis B (HBV), hepatitis C (HCV), know human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness (patients with treated HIV and hepatitis B or C could be included)
  • Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized
  • Uncontrolled diabetes mellitus as defined by a HbA1c \&gt; 9%
  • Prior external beam radiation therapy involving \&gt; 25% of the bone marrow
  • Unmanageable urinary incontinence including physical outflow obstructions rendering the administration of 177Lu-LNC1003 unsafe.
  • Unable to comply with relevant contact precautions post 177Lu-LNC1003 treatment.
  • Any other condition, assessed by the investigator, that may increase the risk associated with study participation, interfere with the study interpretation, or in any other way make the subject unsuitable for participation in the study.

Trial locations and contacts

No sites are listed yet.

A/Prof. Edmund Chiong contact

6908 2222

About this study

Official title: Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in Adult Patients With Prostate Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC.

In the clinical development, we aim to demonstrate the following:

  1. Determination of the therapeutic dose(s) to be used in the expansion phase.
  2. Demonstration of the safety and tolerability of 177Lu-LNC1003 at therapeutic doses.

The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels

Read the detailed description

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC. The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 30 mCi to 70 mCi (1.11 GBq - 2.59 GBq).

This classic "3+3" design recruits 3 patients for the first dose level group. If no dose limiting toxicity (DLT) occurs in the first cycle, then 3 new patients will enter the next higher dose level. If any DLT occurs at a certain dose level, 3 additional patients will be enrolled at this current dose level (in total 6 patients now) to be assessed. The highest dose level(s) at which less than one-third of patients (e.g., 0 of 3 or 1 of 6 patients) experience a DLT will be declared the maximum tolerated dose (MTD). If there is no MTD observed after the dose escalation up to 70 mCi, a comprehensive evaluation should be made by investigator and sponsor to determine whether an escalation to a higher dose can be conducted or not based on the known safety data, radiation doses for similar drugs documented in literature and treatment responses at the doses administered.

Being tested
177Lu-LNC1003 Injection group 1, 177Lu-LNC1003 Injection group 2, 177Lu-LNC1003 Injection group 3

What participants receive

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

  • 177Lu-LNC1003 Injection group 1Drug

    The treatment regimen will consist of a single dose 30 mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

  • 177Lu-LNC1003 Injection group 2Drug

    The treatment regimen will consist of a single dose 50 mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

  • 177Lu-LNC1003 Injection group 3Drug

    The treatment regimen will consist of a single dose 70 mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

Study groups in NCT06237491
Study groupRoleWhat they receive
Experimental: 177Lu-LNC1003 Injection group 1Experimental177Lu-LNC1003 Injection, a single dose of 30mCi will be administered every 6 weeks, for a total of 2 cycles. Interventions: Drug: 177Lu-LNC1003 Injection group 1 radionuclide therapy
Receives: Drug: 177Lu-LNC1003 Injection group 1
Experimental: 177Lu-LNC1003 Injection group 2Experimental177Lu-LNC1003 Injection, a single dose of 50mCi will be administered every 6 weeks, for a total of 2 cycles. Interventions: Drug: 177Lu-LNC1003 Injection group 2 radionuclide therapy
Receives: Drug: 177Lu-LNC1003 Injection group 2
Experimental: 177Lu-LNC1003 Injection group 3Experimental177Lu-LNC1003 Injection, a single dose of 70mCi will be administered every 6 weeks, for a total of 2 cycles. Interventions: Drug: 177Lu-LNC1003 Injection group 3 radionuclide therapy
Receives: Drug: 177Lu-LNC1003 Injection group 3

What is being measured

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

  1. the safety of 177Lu-LNC1003 Injection

    To evaluate the safety of 177Lu-LNC1003 Injection assessed from the number of patients with treatment-related adverse events using CTCAE v5.0.

    Measured: through study completion, assessed up to 2 years.

  2. To identify the dose-limiting toxicities (DLTs)

    To identify DLTs of escalating doses of 177Lu-LNC1003 Injection up to 70 mCi (2.59 GBq) administered intravenously to patients in their first cycle of 6 weeks.

    Measured: through cycle 1, an average of 6 weeks

  3. To determine if the MTD is among the explored dose levels and identify the expansion phase dose

    To determine if the maximum tolerated dose is among the explored dose levels and identify the recommended expansion phase dose of 177Lu-LNC1003 Injection.

    Measured: Through study completion, assessed up to 2 years

Timeline

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

  1. First posted1 Feb 2024
  2. Study start7 May 2025 (estimated)
  3. Primary completion7 Nov 2025 (estimated)
  4. Study completion17 Dec 2025 (estimated)

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
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06237491
Sponsor's protocol ID
177Lu-LNC1003-001
Status last verified
Mar 2024
First submitted
23 Jan 2024
Last updated
24 Jul 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 177Lu-LNC1003 Injection group 1, 177Lu-LNC1003 Injection group 2 and 177Lu-LNC1003 Injection group 3 in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by Yantai LNC Biotechnology Singapore PTE. LTD..

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 22 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact A/Prof. Edmund Chiong (6908 2222), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the safety of 177Lu-LNC1003 Injection (time frame: through study completion, assessed up to 2 years.). The study lists 3 primary outcomes in all. 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 NCT06237491.

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 24 Jul 2024.

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