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Radioiodine Refractory Differentiated Thyroid CancerEarly Phase 1NCT06898437

Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer

A Early Phase 1 study testing 177Lu-LNC1004 Injection in people with Radioiodine Refractory Differentiated Thyroid Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
177Lu-LNC1004 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
24 Mar 2025to 23 Mar 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must have the ability to understand and sign an approved informed consent form (ICF).
  • Aged 18 years or older, regardless of sex.
  • Histologically or cytologically confirmed RAIR-DTC subject who has failed TKIs treatment or refuse standard therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • At least one measurable lesion as defined by Response Criteria in Solid Tumors (RECIST) version 1.1.
  • Life expectancy of at least 6 months.
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  • FAP-positive lesion confirmed by FAPI PET/CT scan.
  • Adequate organ function as defined by：
  • Bone marrow function: hemoglobin ≥ 100 g/L, neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L;
  • Liver function: albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 × ULN; ALT and AST < 3 × ULN without liver metastasis or < 5 × ULN with liver metastasis;
  • Renal function: creatinine clearance ≥ 60 mL/min.
  • Clinically significant toxic reactions related to prior antitumor treatment that have recovered to Grade ≤ 1 (CTCAE V5.0).

Who cannot join

  • Known central nervous system metastases, except for the following:
  • Subject without clinical symptoms can be included in this trial after evaluation by the investigator.
  • Brain metastases that have been previously treated and confirmed by image to be stable for at least 4 weeks.
  • Secondary malignancy was detected within 5 years prior to first dosing, excluding cured localized carcinoma including cervical carcinoma in situ, basal cell skin cancer, and prostate cancer in situ, etc.
  • Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.
  • Subject who previously received targeted therapy, but discontinued treatment for less than 4 weeks or 10 half-lives prior to first dosing.
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  • Received systemic radionuclide therapy or radioembolization within 6 months before first dosing or any external beam radiotherapy within 2 weeks before the first dosing.
  • Known allergy to 177Lu-LNC1004 Injection or similar drugs.
  • Subject has not fully recovered from major surgery prior to first dosing or expects to have major surgery during the study period.
  • Accompanied with severe cardiovascular and cerebrovascular diseases, including but not limited to:
  • Subject who has undergone coronary angioplasty, coronary stent placement, coronary artery bypass grafting, or implantation of defibrillation devices due to arrhythmia within 6 months;
  • There are serious heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.
  • Clinically significant abnormal ECG during the screening period, including QTcF > 470 ms in male and QTcF > 480 ms in female.
  • New York College of Cardiology (NYHA) grade ≥ 3.
  • Aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular event (NCI CTCAE v5.0) within 6 months.
  • Subject who has active and clinically significant bacterial, fungal, viral infection, or any other uncontrolled active infections such as active tuberculosis within 4 weeks prior to first dosing.
  • Known human immunodeficiency virus (HIV) infection or positive HIV test, positive syphilis antibody test, or active hepatitis except for:
  • Subject who is positive for hepatitis B surface antigen can be enrolled if HBV DNA level is less than 1×104 copies/mL or 2000 IU/mL, and can receive antiviral treatment according to clinical judgment during the trial.
  • Subject who is positive for HCV antibodies can be enrolled if HCV RNA test is negative.
  • Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • Subject who has pleural effusion or ascites that required treatment or is deemed uncontrollable by investigator.
  • Subject who has mental illness or substance abuse, which may affect adherence to the trial.
  • Subject who refuses to take effective contraceptive measures during sexual intercourse from ICF signing to 6 months after last investigational drug administration；
  • Women who are pregnant or breastfeeding, or planning to become pregnant during the study period or within 6 months after last investigational drug administration；
  • Any other medical condition, metabolic abnormality, physical abnormality, laboratory abnormality, or other condition that the investigator deems inappropriate for study participation, or that would affect the interpretation of the study results, or place the subject at high risk, such as idiopathic pulmonary fibrosis or lung disease, urinary incontinence, etc.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan-Song Lin, Prof. contact

+86-10-69154713

linys@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Yansong Lin, MD, +86-10-69155610, linys@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Trial to Evaluate the Antitumor Efficacy and Safety of 177Lu-LNC1004 Injection in Patients With Fibroblast Activating Protein (FAP)-Positive Radioiodine-refractory Differentiated Thyroid Cancer (RAIR-DTC) Who Have Failed TKIs Treatment or Refuse Standard Treatment

177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.

Read the detailed description

This prospective, single-arm, open label, single-center clinical trial is planned to enroll approximately 20 RAIR-DTC subjects s who have failed TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles. Disease progression and occurrence of AEs will be monitored during the trial. Based on tumor response assessment and AEs occurrence in the first 2 cycles, subjects may continue to receive 177Lu-LNC1004 Injection for a maximum of 6 cycles.

Being tested
177Lu-LNC1004 Injection
Keywords
Thyroid cancer, 177Lu-LNC1004, FAP
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • 177Lu-LNC1004 InjectionDrug

    Intravenous administration: a single dose of 80 mCi per Cycle

Study groups in NCT06898437
Study groupRoleWhat they receive
177Lu-LNC1004 InjectionExperimentalAll subjects will be administered with 177Lu-LNC1004 Injection at 80 mCi per cycle for 2 cycles with interval of 6 weeks.
Receives: Drug: 177Lu-LNC1004 Injection

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR is defined as the the proportion of subjects who achieve a best overall response of Complete Response (CR) or Partial Response (PR).

    Measured: up to 24 months

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    DCR is defined as the proportion of subjects who achieve a best overall response of CR, PR or Stable Disease (SD).

    Measured: up to 24 months

  2. Duration of Response (DoR)

    DoR is defined as the time from the earliest date of documented CR or PR until documented disease progression or death, whichever occurs first.

    Measured: up to 24 months

  3. Progression Free Survival (PFS)

    PFS is defined as the time from the first dose of 177Lu-LNC1004 Injection to the date of documented disease progression or death, whichever occurs first.

    Measured: up to 24 months

  4. Biochemical Response (BR)

    BR is defined as the percentage of change in serum Thyroglobulin (Tg) from baseline.

    Measured: up to 24 months

  5. Safety

    Adverse Event (AE), Serious Adverse Event (SAE), Treatment related Adverse Event (TRAE).

    Measured: up to 24 months

Timeline

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

  1. First posted27 Mar 2025
  2. Study start24 Mar 2025
  3. Primary completion23 Mar 2026 (estimated)
  4. Study completion23 Mar 2027 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06898437
Sponsor's protocol ID
K7531
Status last verified
Apr 2025
First submitted
21 Mar 2025
Last updated
15 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 177Lu-LNC1004 Injection in people with Radioiodine Refractory Differentiated Thyroid Cancer, run by Peking Union Medical College Hospital at 1 site in China.

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 12 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 15 Apr 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 China. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Yan-Song Lin, Prof. (+86-10-69154713, linys@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: up to 24 months). 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 NCT06898437.

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 15 Apr 2025.

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