Metastatic Solid Tumors (Any Localization)Early Phase 1NCT07587996
Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
A Early Phase 1 study testing radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI in people with Metastatic Solid Tumors (Any Localization), run by Lanzhou University Second Hospital at 1 site in China.
Trial summary
This is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer. The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors (Any Localization)
- What is being tested?
- radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 20 Apr 2026
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis confirmed metastatic solid tumors (breast cancer, sarcoma, and some thyroid cancers, etc.) that failed standard treatment or lacked standard treatment
- Age: 75 ≥ age ≥ 18 years
- ECOG score: 0 - 2
- 68Ga-CTR-FAPI PET/CT confirmed high expression of FAP in the tumor (more than 50% of the lesions with SUVmax ≥ 10)
- The FAP immunohistochemical score of tumor cells is ≥ 2 (except for thyroid cancer)
- There is at least one measurable lesion (RECIST 1.1)
- Organ/marrow functions meet the specified thresholds, and there are no severe electrocardiogram abnormalities (QTcF ≤ 470ms)
Who cannot join
- There is brain metastasis or other central nervous system lesions.
- The expected survival period is less than 6 months.
- Within 4 weeks before administration, the patient has received chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments or investigational drugs.
- The patient has previously received other systemic radionuclide therapy (excluding 131I treatment for thyroid cancer).
- There is uncontrolled pleural effusion, ascites, severe cardiovascular or cerebrovascular diseases, or infection.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, 730000
About this study
Official title: An Exploratory Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
This is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer.
The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. The study will also assess its in vivo biodistribution, radiation absorbed dose in normal organs and target lesions, and preliminary clinical efficacy.
The main question this study aims to answer is whether ¹⁷⁷Lu-CTR-FAPI can be administered safely and shows sufficient tumor-targeting and preliminary therapeutic activity to support further clinical investigation in patients with FAP-high expressing metastatic solid tumors.
Read the detailed description
This is an investigator-initiated, single-center, non-randomized, single-arm, open-label exploratory clinical trial of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors.
Participants will receive ¹⁷⁷Lu-CTR-FAPI by intravenous infusion. The planned standard activity is 200 mCi (7.4 GBq) ±10%, administered every 6±1 weeks for up to 4 cycles. Dose reduction to 100 mCi (3.7 GBq) may be performed according to predefined toxicity criteria.
During the first treatment cycle, participants will undergo intensive blood sampling and serial imaging to evaluate biodistribution and radiation dosimetry. Whole-body planar imaging and localized quantitative SPECT/CT will be performed at multiple time points from approximately 1 hour to 7-9 days after the initial administration. Regions of interest will be drawn for source organs and target lesions, and time-activity curves will be generated to estimate cumulative activity. Absorbed doses to normal organs and tumor lesions will be calculated using OLINDA/EXM software.
Safety will be monitored throughout the study by vital signs, physical examinations, laboratory tests, 12-lead electrocardiograms, and adverse event recording. Adverse events will be coded and graded according to CTCAE v5.0, with particular attention to hematologic, hepatic, and renal toxicities.
Tumor imaging evaluations will be performed according to the study schedule. Preliminary efficacy will be assessed using RECIST 1.1, including objective response rate and progression-free survival. Statistical analyses will be descriptive, and missing data will not be imputed.
- Being tested
- radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radionuclide therapy with ¹⁷⁷Lu-CTR-FAPIDrug
a novel covalent targeted radioligand (CTR), ¹⁷⁷Lu-CTR-FAPI, utilizing a sulfur(VI) fluoride exchange (SuFEx) click chemistry-based strategy
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced metastatic solid tumors | Experimental | Not described Receives: Drug: radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation. Adverse events will be coded and graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Measured: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
Number of Participants With Abnormal Vital Signs
Number of participants with clinically significant abnormal vital signs, including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation, as determined by the investigator.
Measured: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
Number of Participants With Abnormal Laboratory Test Results
Number of participants with clinically significant abnormal laboratory test results, including complete blood count, liver function tests, renal function tests, and serum electrolytes, graded according to the Common Terminology Criteria for Adverse Events version 5.0 when applicable.
Measured: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
Secondary outcomes (3)
Objective Response Rate
Objective response rate is defined as the proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
Measured: Every 8 weeks from baseline until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 12 months
Progression-Free Survival
Progression-free survival is defined as the time from the first administration of [¹⁷⁷Lu]Lu-CTR-FAPI to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI until disease progression or death, up to 12 months
Radiation dosimetry
Through whole-body planar imaging, local SPECT/CT quantitative tomographic imaging combined with blood sample determination, the radiation absorption doses of normal organs and target lesions were calculated using the OLINDA/EXM software.
Measured: It should be measured within 1 hour to 7 to 9 days after the first administration of the drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start20 Nov 2024
- Primary completion20 Mar 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid Tumors (Any Localization)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangyan Liu, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587996
- Sponsor's protocol ID
- 2024A-1337
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07587996
- Acronym / sponsor ID
- 2024A-1337
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 14 May 2026 (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 is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer.
The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. The study will also assess its in vivo biodistribution, radiation absorbed dose in normal organs and target lesions, and preliminary clinical efficacy.
The main question this study aims to answer is whether ¹⁷⁷Lu-CTR-FAPI can be administered safely and shows sufficient tumor-targeting and preliminary therapeutic activity to support further clinical investigation in patients with FAP-high expressing metastatic solid tumors.
Detailed description
This is an investigator-initiated, single-center, non-randomized, single-arm, open-label exploratory clinical trial of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors.
Participants will receive ¹⁷⁷Lu-CTR-FAPI by intravenous infusion. The planned standard activity is 200 mCi (7.4 GBq) ±10%, administered every 6±1 weeks for up to 4 cycles. Dose reduction to 100 mCi (3.7 GBq) may be performed according to predefined toxicity criteria.
During the first treatment cycle, participants will undergo intensive blood sampling and serial imaging to evaluate biodistribution and radiation dosimetry. Whole-body planar imaging and localized quantitative SPECT/CT will be performed at multiple time points from approximately 1 hour to 7-9 days after the initial administration. Regions of interest will be drawn for source organs and target lesions, and time-activity curves will be generated to estimate cumulative activity. Absorbed doses to normal organs and tumor lesions will be calculated using OLINDA/EXM software.
Safety will be monitored throughout the study by vital signs, physical examinations, laboratory tests, 12-lead electrocardiograms, and adverse event recording. Adverse events will be coded and graded according to CTCAE v5.0, with particular attention to hematologic, hepatic, and renal toxicities.
Tumor imaging evaluations will be performed according to the study schedule. Preliminary efficacy will be assessed using RECIST 1.1, including objective response rate and progression-free survival. Statistical analyses will be descriptive, and missing data will not be imputed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced metastatic solid tumors | Experimental | Drug: radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathological diagnosis confirmed metastatic solid tumors (breast cancer, sarcoma, and some thyroid cancers, etc.) that failed standard treatment or lacked standard treatment
- Age: 75 ≥ age ≥ 18 years
- ECOG score: 0 - 2
- 68Ga-CTR-FAPI PET/CT confirmed high expression of FAP in the tumor (more than 50% of the lesions with SUVmax ≥ 10)
- The FAP immunohistochemical score of tumor cells is ≥ 2 (except for thyroid cancer)
Key exclusion criteria (5 listed)
- There is brain metastasis or other central nervous system lesions.
- The expected survival period is less than 6 months.
- Within 4 weeks before administration, the patient has received chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments or investigational drugs.
- The patient has previously received other systemic radionuclide therapy (excluding 131I treatment for thyroid cancer).
- There is uncontrolled pleural effusion, ascites, severe cardiovascular or cerebrovascular diseases, or infection.
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 |
|---|---|---|
| radionuclide therapy with ¹⁷⁷Lu-CTR-FAPIa novel covalent targeted radioligand (CTR), ¹⁷⁷Lu-CTR-FAPI, utilizing a sulfur(VI) fluoride exchange (SuFEx) click chemistry-based strategy | Drug | Patients with advanced metastatic solid tumors |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
Number of participants with treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation. Adverse events will be coded and graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Number of Participants With Abnormal Vital Signs
Time frame: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
Number of participants with clinically significant abnormal vital signs, including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation, as determined by the investigator.
Number of Participants With Abnormal Laboratory Test Results
Time frame: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
Number of participants with clinically significant abnormal laboratory test results, including complete blood count, liver function tests, renal function tests, and serum electrolytes, graded according to the Common Terminology Criteria for Adverse Events version 5.0 when applicable.
3 secondary outcomes
Objective Response Rate
Time frame: Every 8 weeks from baseline until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 12 months
Progression-Free Survival
Time frame: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI until disease progression or death, up to 12 months
Radiation dosimetry
Time frame: It should be measured within 1 hour to 7 to 9 days after the first administration of the drug.
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 14 May 2026.
- Individual participant dataSharing planned: No
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 Early Phase 1 study testing radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI in people with Metastatic Solid Tumors (Any Localization), run by Lanzhou University Second 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 7 inclusion and 5 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 14 May 2026. 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?
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?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration). 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 14 May 2026.