The Safety and Dosimetry Study of 177Lu-LNC1004 Injection

NCT05723640 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 177Lu-LNC1004-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal is a phase I, open-label study of a 4-Dose Regimen of Escalating Doses of 177Lu-LNC1004 Injection in patients with recurrent or metastatic, fibroblast activation protein-positive solid tumors. In the clinical development, we aim to demonstrate the following:

• 177Lu-LNC1004 Injection is safe and tolerable at therapeutic dose.
• Determination of dose(s) to be used in the expansion phase. The treatment regimen will consist of a single dose intravenous administration of 177Lu-LNC1004 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 4 different dose levels

Conditions

Solid Tumor, Unspecified, Adult

Outcome Measures

Primary Outcomes (3)

• the safety of 177Lu-LNC1004 Injection

  To evaluate the safety of 177Lu-LNC1004 Injection assessed from the number of patients with treatment-related adverse events using CTCAE v5.0.

  through study completion, assessed up to 2 years.

• To identify the dose-limiting toxicities (DLTs)

  To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-LNC1004 up to 100 mCi (3.7 GBq) administered intravenously to patients in the first cycle.

  through cycle 1, an average of 6 weeks

• 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 expansion phase dose of 177Lu-LNC1004 Injection.

  through study completion, assessed up to 2 years.

Study Arms (4)

177Lu-LNC1004 Injection group 1

EXPERIMENTAL

177Lu-LNC1004 Injection, a single dose of 30mCi will be administered every 6 weeks, for a total of 2 cycles.

Drug: 177Lu-LNC1004 Injection group 1 radionuclide therapy

177Lu-LNC1004 Injection group 2

EXPERIMENTAL

177Lu-LNC1004 Injection, a single dose of 60mCi will be administered every 6 weeks, for a total of 2 cycles.

Drug: 177Lu-LNC1004 Injection group 2 radionuclide therapy

177Lu-LNC1004 Injection group 3

EXPERIMENTAL

177Lu-LNC1004 Injection, a single dose of 80mCi will be administered every 6 weeks, for a total of 2 cycles.

Drug: 177Lu-LNC1004 Injection group 3 radionuclide therapy

177Lu-LNC1004 Injection group 4

EXPERIMENTAL

177Lu-LNC1004 Injection, a single dose of 100mCi will be administered every 6 weeks, for a total of 2 cycles.

Drug: 177Lu-LNC1004 Injection group 4 radionuclide therapy

Interventions

177Lu-LNC1004 Injection group 1 radionuclide therapy DRUG

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

177Lu-LNC1004 Injection group 1

177Lu-LNC1004 Injection group 2 radionuclide therapy DRUG

The treatment regimen will consist of a single dose 60mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

177Lu-LNC1004 Injection group 2

177Lu-LNC1004 Injection group 3 radionuclide therapy DRUG

The treatment regimen will consist of a single dose 80mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

177Lu-LNC1004 Injection group 3

177Lu-LNC1004 Injection group 4 radionuclide therapy DRUG

The treatment regimen will consist of a single dose 100mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

177Lu-LNC1004 Injection group 4

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 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.
• Aged 21 years or older
• Patients must have histological, pathological, and/or cytological confirmation of advanced/metastatic solid tumor that is refractory to or has progressed following prior treatment and based on the current guidelines, there is no recommended treatment
• Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1
• Overexpression of fibroblast activation protein of the target lesions at 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) with positive uptake (higher than adjacent background).
• Eastern Cooperative Oncology Group (ECOG) performance status (ECOG PS) score of 0 or 1
• Adequate organ function as defined by:
• Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)
• Hemoglobin (Hb) \> 9.0g/dL
• Absolute neutrophil count (ANC) \> 1.5 x 10\^9/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

You may not qualify if:

• Women who are pregnant or breastfeeding
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-LNC1004 as assessed from medical records
• Participant has had prior chemotherapy or radical radiotherapy within 4 weeks before the first administration of study drug
• Participant has had prior targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent ≤ 14 days prior to receiving study treatment (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies) before the first administration of study drug.
• Received prior radiopharmaceutical therapy or radioembolization, or prior extensive external beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney, or received any EBRT within 2 weeks prior to administration of study treatment
• Participant has not fully recovered from major surgery or significant traumatic injury prior 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 \< 6 months as assessed by the treating physician
• \> 80% liver involvement by tumor
• \> 25% bone marrow involvement by tumor
• Clinically significant abnormalities on electrocardiogram (ECG) at screening including QTcF \> 470 ms regardless of sex or subjects who cannot tolerate high volume load.
• Toxicities from prior therapies that have not resolved to grade 1 or grade 0
• Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HBC), know human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
• Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized
• Uncontrolled diabetes mellitus as defined by a HbA1c \>9%
• Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Yantai LNC Biotechnology Singapore PTE. LTD.: lead

Study Sites (1)

National University Cancer Institute, Singapore National University Hospital, Singapore.

Singapore, 119077, Singapore

Location

Study Design

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

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: October 3, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)