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.
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
- Conditions the study is for
- Radioiodine Refractory Differentiated Thyroid Cancer
- 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.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Yansong Lin, MD, +86-10-69155610, linys@pumch.cn
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 group | Role | What they receive |
|---|---|---|
| 177Lu-LNC1004 Injection | Experimental | All 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.
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)
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
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
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
Biochemical Response (BR)
BR is defined as the percentage of change in serum Thyroglobulin (Tg) from baseline.
Measured: up to 24 months
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.
- First posted27 Mar 2025
- Study start24 Mar 2025
- Primary completion23 Mar 2026 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radioiodine Refractory Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yansong Lin, Peking Union Medical College Hospital
- Investigators
- Peking Union Medical College Hospital, Principal investigator, Peking Union Medical College Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06898437
- Acronym / sponsor ID
- K7531
- Keywords
- Thyroid cancer, 177Lu-LNC1004, FAP
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 23 Mar 2026 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 27 Mar 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-LNC1004 Injection | Experimental | Drug: 177Lu-LNC1004 InjectionAll subjects will be administered with 177Lu-LNC1004 Injection at 80 mCi per cycle for 2 cycles with interval of 6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (25 listed)
- Known central nervous system metastases, except for the following:
- 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.
- Received systemic radionuclide therapy or radioembolization within 6 months before first dosing or any external beam radiotherapy within 2 weeks before the first dosing.
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 InjectionIntravenous administration: a single dose of 80 mCi per Cycle | Drug | 177Lu-LNC1004 Injection |
Primary outcome
Overall Response Rate (ORR)
Time frame: up to 24 months
ORR is defined as the the proportion of subjects who achieve a best overall response of Complete Response (CR) or Partial Response (PR).
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 24 months
Duration of Response (DoR)
Time frame: up to 24 months
Progression Free Survival (PFS)
Time frame: up to 24 months
Biochemical Response (BR)
Time frame: up to 24 months
Safety
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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Radioiodine-refractory Differentiated Thyroid Cancer
Recruiting
Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer
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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.
Peking Union Medical College Hospital principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.