Pancreatic CancerEarly Phase 1NCT07229768
Clinical Study of 177Lu-CTR-FAPI In the Treatment of Patients With Advanced, Metastatic Solid Tumors
A Early Phase 1 study testing 177Lu-CTR-FAPI in people with Pancreatic Cancer, run by Yan Xing at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label clinical study of 177Lu-CTR-FAPI injection in the treatment of patients with advanced, metastatic solid tumors i.e. pancreatic cancer, to assess safety, radio-dosimetry, and efficacy per RESIST 1.1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 177Lu-CTR-FAPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 31 Dec 2026
- 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
- 1: Patients with unresectable, advanced, or metastatic solid tumors who have been histologically or cytologically confirmed, have failed standard treatment, lack standard treatment options, or refuse standard treatment. Preferred tumor types include pancreatic cancer, breast cancer, and soft tissue sarcoma, and must meet any of the following tumor-specific criteria:
- Patients with advanced or metastatic TNBC who have progressed after or are intolerant to at least 2 lines of systemic therapy;
- Patients with HER2-positive advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of HER2-targeted therapy;
- Patients with HR/HER2-negative advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of systemic therapy;
- Patients with advanced or metastatic high-grade soft tissue sarcoma (excluding chordoma) who have progressed after or are intolerant to at least 1 line of systemic therapy;
- Patients with advanced or metastatic pancreatic cancer who have progressed after or are intolerant to at least 1 line of systemic therapy.
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- 2: Age >= 18 years, regardless of sex;
- 3: Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures;
- 4: ECOG performance status score of 0 or 1;
- 5: FAP expression in tumor lesions confirmed positive by FAPI PET/CT;
- 6: Agree to provide archived or fresh tumor tissue for immunohistochemical evaluation (if available);
- 7: At least 1 measurable lesion according to RECIST 1.1 criteria;
- 8: Previous anti-tumor toxicities recovered to grade 0-1;
- 9: Organ function meets requirements before first administration;
- Hematology: Absolute neutrophil count (ANC) >= 1.5×10^9/L; Hemoglobin (Hb) >= 80 g/L; Platelet count (PLT) >= 75×10^9/L;
- Liver function: Total bilirubin (TB) <= 1.5×ULN; AST and ALT <= 3×ULN, and if there is hepatic tumor metastasis, ALT and AST <= 5×ULN;
- Renal function: Creatinine clearance >= 50 mL/min (Cockcroft-Gault formula); ECG: QTcF <= 470 ms;
- 10: Fertile subjects voluntarily use effective contraception during treatment and for 4 months (male) or 7 months (female) after the last dose of study drug.
Who cannot join
- 1: Subjects with brain metastases, meningiomas, or other central nervous system lesions at screening
- 2: Severe allergy to contrast agents or claustrophobia
- 3: Expected survival period < 6 months
- 4: Receipt of blood transfusion within 2 weeks before the first dose to meet the eligibility criteria
- 5: Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose
- 6: Participation in other clinical trials involving investigational drugs or devices within 4 weeks before the first dose
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- 7: Major surgery within 4 weeks before the first dose or planned major surgery during the study period
- 8: Active bacterial, fungal, viral, or other infections requiring intravenous medication within 4 weeks before the first dose
- 9: Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose
- 10: History of other malignancies within 5 years before the first dose
- 11: Severe cardiovascular or cerebrovascular diseases, or poorly controlled diabetes
- 12: Presence of pleural effusion or ascites requiring treatment or judged by the investigator as uncontrolled at screening
- 13: Females who are pregnant or breastfeeding
- 14: Subjects considered by the investigator to have poor compliance and inability to cooperate with treatment and follow-up at screening.
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
Shanghai General Hospital
Shanghai
Principal Imvestigator, 0086 021-36126102, xy.1@163.com
About this study
Official title: A Single-Center, Single-Arm, Open-Label Clinical Study of 177Lu-CTR-FAPI Injection in the Treatment of Patients With Advanced, Metastatic Solid Tumors
This is a single-center, single-arm, open-label clinical study of 177Lu-CTR-FAPI injection in the treatment of patients with advanced, metastatic solid tumors i.e. pancreatic cancer, to assess safety, radio-dosimetry, and efficacy per RESIST 1.1.
- Conditions
- Pancreatic Cancer
- Being tested
- 177Lu-CTR-FAPI
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-CTR-FAPIDrug
The medication is administered intravenously, with a single dose of 200 mCi (7.4 GBq) ±10%, administered once every 6 ± 2 weeks. The planned course consists of 4 doses, or until the radiation safety threshold for major organs is reached based on radiation dosimetry assessment.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-CTR-FAPI Treatment Arm | Experimental | Not described Receives: Drug: 177Lu-CTR-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Adeverse Events
Measured: From enrolment to 12 months after the first dose
Secondary outcomes (2)
Radiation Dosimetry
Measured: one week after first dose
ORR
Objective Response Rate
Measured: From first dose to 12 months afer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start15 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Xing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Xing, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229768
- Sponsor's protocol ID
- IIT2025-139
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Open-Label Clinical Study of 177Lu-CTR-FAPI Injection in the Treatment of Patients With Advanced, Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07229768
- Acronym / sponsor ID
- IIT2025-139
- Conditions
- Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Yan XingUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 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.
This is a single-center, single-arm, open-label clinical study of 177Lu-CTR-FAPI injection in the treatment of patients with advanced, metastatic solid tumors i.e. pancreatic cancer, to assess safety, radio-dosimetry, and efficacy per RESIST 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-CTR-FAPI Treatment Arm | Experimental | Drug: 177Lu-CTR-FAPI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1: Patients with unresectable, advanced, or metastatic solid tumors who have been histologically or cytologically confirmed, have failed standard treatment, lack standard treatment options, or refuse standard treatment. Preferred tumor types include pancreatic cancer, breast cancer, and soft tissue sarcoma, and must meet any of the following tumor-specific criteria:
- 2: Age >= 18 years, regardless of sex;
- 3: Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures;
- 4: ECOG performance status score of 0 or 1;
- 5: FAP expression in tumor lesions confirmed positive by FAPI PET/CT;
Key exclusion criteria (14 listed)
- 1: Subjects with brain metastases, meningiomas, or other central nervous system lesions at screening
- 2: Severe allergy to contrast agents or claustrophobia
- 3: Expected survival period < 6 months
- 4: Receipt of blood transfusion within 2 weeks before the first dose to meet the eligibility criteria
- 5: Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose
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-CTR-FAPIThe medication is administered intravenously, with a single dose of 200 mCi (7.4 GBq) ±10%, administered once every 6 ± 2 weeks. The planned course consists of 4 doses, or until the radiation safety threshold for major organs is reached based on radiation dosimetry assessment. | Drug | 177Lu-CTR-FAPI Treatment Arm |
Primary outcome
AE
Time frame: From enrolment to 12 months after the first dose
Adeverse Events
2 secondary outcomes
Radiation Dosimetry
Time frame: one week after first dose
ORR
Time frame: From first dose to 12 months afer
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 17 Nov 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.
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-CTR-FAPI in people with Pancreatic Cancer, run by Yan Xing 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 18 inclusion and 14 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 17 Nov 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 Xing (+86 21-36126600, xy.1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: From enrolment to 12 months after the first dose). 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 17 Nov 2025.