Solid Tumor, Unspecified, AdultPhase 1NCT05723640
The Safety and Dosimetry Study of 177Lu-LNC1004 Injection
A Phase 1 study testing 177Lu-LNC1004 Injection group 1 radionuclide therapy, 177Lu-LNC1004 Injection group 2 radionuclide therapy and 177Lu-LNC1004 Injection group 3 radionuclide therapy in people with Solid Tumor, Unspecified, Adult, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Solid Tumor, Unspecified, Adult
- What is being tested?
- 177Lu-LNC1004 Injection group 1 radionuclide therapy, 177Lu-LNC1004 Injection group 2 radionuclide therapy and 177Lu-LNC1004 Injection group 3 radionuclide therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Oct 2023to 25 Sep 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
- Serum albumin > 2.8 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
- All other toxicity parameters must be NCI-CTCAE v.5.0 Grade 0 or 1
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at study entry. Subjects not considered WOCBP are those without menses for ≥ 12 consecutive months, and those who have undergone hysterectomy and/or bilateral salpingo-oophorectomy. WOCBP must be willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study and 6 months after the last dose of treatment.
- Male participants with partners of childbearing potential are required to use barrier contraception in addition to having their partner use another method of contraception during the study and for 6 months after the last dose of treatment. Male participants will also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.
- Previous surgery no less than 4 weeks prior to study entry.
Who cannot join
- 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.
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- 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
- Prior external beam radiation therapy involving >25% of the bone marrow
- Unmanageable urinary incontinence rendering the administration of 177Lu-LNC1004 unsafe
- Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence
- Unable to comply with relevant contact precautions post 177Lu-LNC1004 treatment
- Any other condition that may increase the risk associated with study participation or interfere with its interpretation.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Cancer Institute, Singapore National University Hospital, Singapore.
Singapore, 119077
About this study
Official title: Phase I, Open-Label Study of the Safety and Dosimetry of a 4-Dose Regimen of Escalating Doses of 177Lu-LNC1004 Injection in Adult Patients With Advanced Fibroblast Activation Protein (FAP)-Positive Solid Tumors
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
Read the detailed description
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. 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, from 30 mCi to 100 mCi (1.11 - 3.7 GBq).
This classic 3+3 design includes 3 patients for the first dose level group. If no DLT occurs, 3 patients will be enrolled at the next dose level. If a DLT occurs at a certain dose level, 3 additional patients will be enrolled at the previous dose level. The highest dose with no more than 1 DLT out of 6 patients will be defined as MTD. If there is no MTD observed after the dose escalation up to 100 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, radiation dose and efficacy characteristics.
- Conditions
- Solid Tumor, Unspecified, Adult
- Being tested
- 177Lu-LNC1004 Injection group 1 radionuclide therapy, 177Lu-LNC1004 Injection group 2 radionuclide therapy, 177Lu-LNC1004 Injection group 3 radionuclide therapy, 177Lu-LNC1004 Injection group 4 radionuclide therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-LNC1004 Injection group 1 radionuclide therapyDrug
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 2 radionuclide therapyDrug
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 3 radionuclide therapyDrug
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 4 radionuclide therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: 177Lu-LNC1004 Injection group 4 radionuclide therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
- First posted13 Feb 2023
- Study start3 Oct 2023
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, Unspecified, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yantai LNC Biotechnology Singapore PTE. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723640
- Sponsor's protocol ID
- 177Lu-LNC1004-001
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study of the Safety and Dosimetry of a 4-Dose Regimen of Escalating Doses of 177Lu-LNC1004 Injection in Adult Patients With Advanced Fibroblast Activation Protein (FAP)-Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT05723640
- Acronym / sponsor ID
- 177Lu-LNC1004-001
- Conditions
- Solid Tumor, Unspecified, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Yantai LNC Biotechnology Singapore PTE. LTD.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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. 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, from 30 mCi to 100 mCi (1.11 - 3.7 GBq).
This classic 3+3 design includes 3 patients for the first dose level group. If no DLT occurs, 3 patients will be enrolled at the next dose level. If a DLT occurs at a certain dose level, 3 additional patients will be enrolled at the previous dose level. The highest dose with no more than 1 DLT out of 6 patients will be defined as MTD. If there is no MTD observed after the dose escalation up to 100 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, radiation dose and efficacy characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 177Lu-LNC1004 Injection group 1 | Experimental | Drug: 177Lu-LNC1004 Injection group 1 radionuclide therapy177Lu-LNC1004 Injection, a single dose of 30mCi will be administered every 6 weeks, for a total of 2 cycles. |
| 177Lu-LNC1004 Injection group 2 | Experimental | Drug: 177Lu-LNC1004 Injection group 2 radionuclide therapy177Lu-LNC1004 Injection, a single dose of 60mCi will be administered every 6 weeks, for a total of 2 cycles. |
| 177Lu-LNC1004 Injection group 3 | Experimental | Drug: 177Lu-LNC1004 Injection group 3 radionuclide therapy177Lu-LNC1004 Injection, a single dose of 80mCi will be administered every 6 weeks, for a total of 2 cycles. |
| 177Lu-LNC1004 Injection group 4 | Experimental | Drug: 177Lu-LNC1004 Injection group 4 radionuclide therapy177Lu-LNC1004 Injection, a single dose of 100mCi will be administered every 6 weeks, for a total of 2 cycles. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-LNC1004 Injection group 1 radionuclide therapyThe 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. | Drug | 177Lu-LNC1004 Injection group 1 |
| 177Lu-LNC1004 Injection group 2 radionuclide therapyThe 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. | Drug | 177Lu-LNC1004 Injection group 2 |
| 177Lu-LNC1004 Injection group 3 radionuclide therapyThe 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. | Drug | 177Lu-LNC1004 Injection group 3 |
| 177Lu-LNC1004 Injection group 4 radionuclide therapyThe 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. | Drug | 177Lu-LNC1004 Injection group 4 |
Primary outcome
the safety of 177Lu-LNC1004 Injection
Time frame: through study completion, assessed up to 2 years.
To evaluate the safety of 177Lu-LNC1004 Injection assessed from the number of patients with treatment-related adverse events using CTCAE v5.0.
To identify the dose-limiting toxicities (DLTs)
Time frame: through cycle 1, an average of 6 weeks
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.
To determine if the MTD is among the explored dose levels and identify the expansion phase dose
Time frame: through study completion, assessed up to 2 years.
To determine if the maximum tolerated dose is among the explored dose levels and identify the expansion phase dose of 177Lu-LNC1004 Injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 177Lu-LNC1004 Injection group 1 radionuclide therapy, 177Lu-LNC1004 Injection group 2 radionuclide therapy and 177Lu-LNC1004 Injection group 3 radionuclide therapy in people with Solid Tumor, Unspecified, Adult, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in Singapore.
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 20 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 8 Sep 2025. 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 Singapore. 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?
the safety of 177Lu-LNC1004 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?
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 8 Sep 2025.