Fibroblast Activation Protein (FAP)-Positive Advanced Solid TumoursEarly Phase 1NCT07808177
Clinical Evaluation of 177Lu-FAP-VG11 Injection in Patients With Fibroblast Activation Protein -Positive Advanced Solid Tumours
A Early Phase 1 study testing 177Lu-FAP-VG11 in people with Fibroblast Activation Protein (FAP)-Positive Advanced Solid Tumours, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This is an exploratory clinical study evaluating the safety, tolerability and biodistribution characteristics of 177Lu-FAP-VG11 injection in patients with FAP-positive advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibroblast Activation Protein (FAP)-Positive Advanced Solid Tumours
- What is being tested?
- 177Lu-FAP-VG11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2026to 6 May 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
- Patients whose tumors are assessed as FAP-positive (high FAP expression with SUVmax uptake above liver background) by FAP-targeted diagnostic PET/CT imaging.
- In the investigator's judgment, no other treatment option with curative or life-prolonging potential is available.
- Male or non-pregnant, non-lactating females, aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Life expectancy >6 months.
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- Female patients: Women of childbearing potential must agree to use highly effective contraceptive methods from screening until 6 months after the last dose of study drug.
- Male patients: Subjects must use a condom during sexual intercourse during the study and for 14 weeks after the last study treatment to prevent partner pregnancy and to avoid transmission of the study drug via semen; in addition, subjects should refrain from sperm donation during treatment and for 6 months after the last study drug administration.
- Subjects must provide written informed consent voluntarily before participation in the trial.
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Clinically symptomatic central nervous system metastases or meningeal metastases, or other evidence that the patient's central nervous system or meningeal metastases are not controlled, and deemed unsuitable for enrollment by the investigator.
- Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of study drug, or need for elective surgery during the study period.
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or severe autoimmune disease history deemed unsuitable for enrollment by the investigator; or allogeneic organ transplantation requiring immunosuppressive therapy.
- Receipt of systemic or local radioisotope therapy within 3 months prior to the first dose.
- Receipt of other investigational drugs not yet marketed within 4 weeks prior to the first use of study drug, or within five half-lives of the other investigational drug.
- Definitive history of neurological or psychiatric disorders, including epilepsy or dementia.
- Pregnancy or lactation, or unwillingness to use adequate contraceptive methods.
- Any severe concomitant disease that, in the investigator's opinion, would make the patient's participation in the study inadvisable or could affect compliance with the protoco.
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
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Xiaorong Sun, 0531-67626287, xrsun@sdfmu.edu.cn
About this study
Official title: An Exploratory Clinical Study to Evaluate the Safety, Tolerability and Biodistribution Characteristics of 177 Lu FAP VG11 Injection in Patients With Advanced Solid Tumours
This is an exploratory clinical study evaluating the safety, tolerability and biodistribution characteristics of 177Lu-FAP-VG11 injection in patients with FAP-positive advanced solid tumours.
Read the detailed description
This is an exploratory, single-arm, dose-escalation, open-label early Phase I clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of 177Lu-FAP-VG11 injection in FAP-positive patients with advanced solid tumors.
- Being tested
- 177Lu-FAP-VG11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-FAP-VG11Drug
Patients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-FAP-VG11 injection treatment | Experimental | Patients will be treated with 177Lu-FAP-VG11 Injection Receives: Drug: 177Lu-FAP-VG11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLT)
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Measured: Through study completion, assessed up to 2 years.
Maximum Tolerate dose (MTD)
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Measured: Through study completion, assessed up to 2 years.
Adverse Events
Patients adverse events Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v6.0.All Adverse Events (AEs) occurring during the clinical study period will be monitored.
Measured: Through study completion, assessed up to 2 years.
Biodistribution
Evaluation of drug biodistribution in major human organs.
Measured: Through study completion, assessed up to 2 years.
Radiation dosimetry
Standard uptake value (SUV).
Measured: Through study completion, assessed up to 2 years.
Radiation dosimetry
Organ accumulation (%ID).
Measured: Through study completion, assessed up to 2 years.
Radiation dosimetry
Absorbed dose (AD).
Measured: Through study completion, assessed up to 2 years.
Radiation dosimetry
Effective dose (ED) in tumors and target organs.
Measured: Through study completion, assessed up to 2 years.
Secondary outcomes (2)
Objective 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: Through study completion, assessed up to 2 years.
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: 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 posted8 Sep 2026
- Study start17 Jun 2026
- Primary completion6 May 2027 (estimated)
- Study completion6 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroblast Activation Protein (FAP)-Positive Advanced Solid TumoursStudies 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
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Sun, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808177
- Sponsor's protocol ID
- SDZLEC2026-049-001
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 14 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Safety, Tolerability and Biodistribution Characteristics of 177 Lu FAP VG11 Injection in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT07808177
- Acronym / sponsor ID
- SDZLEC2026-049-001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 6 May 2029 (estimated)
- First posted
- 8 Sep 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 an exploratory clinical study evaluating the safety, tolerability and biodistribution characteristics of 177Lu-FAP-VG11 injection in patients with FAP-positive advanced solid tumours.
Detailed description
This is an exploratory, single-arm, dose-escalation, open-label early Phase I clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of 177Lu-FAP-VG11 injection in FAP-positive patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-FAP-VG11 injection treatment | Experimental | Drug: 177Lu-FAP-VG11Patients will be treated with 177Lu-FAP-VG11 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
- Patients whose tumors are assessed as FAP-positive (high FAP expression with SUVmax uptake above liver background) by FAP-targeted diagnostic PET/CT imaging.
- In the investigator's judgment, no other treatment option with curative or life-prolonging potential is available.
- Male or non-pregnant, non-lactating females, aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
Key exclusion criteria (8 listed)
- Clinically symptomatic central nervous system metastases or meningeal metastases, or other evidence that the patient's central nervous system or meningeal metastases are not controlled, and deemed unsuitable for enrollment by the investigator.
- Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of study drug, or need for elective surgery during the study period.
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or severe autoimmune disease history deemed unsuitable for enrollment by the investigator; or allogeneic organ transplantation requiring immunosuppressive therapy.
- Receipt of systemic or local radioisotope therapy within 3 months prior to the first dose.
- Receipt of other investigational drugs not yet marketed within 4 weeks prior to the first use of study drug, or within five half-lives of the other investigational drug.
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-FAP-VG11Patients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose. | Drug | 177Lu-FAP-VG11 injection treatment |
Primary outcome
Dose-Limiting Toxicities (DLT)
Time frame: Through study completion, assessed up to 2 years.
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Maximum Tolerate dose (MTD)
Time frame: Through study completion, assessed up to 2 years.
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Adverse Events
Time frame: Through study completion, assessed up to 2 years.
Patients adverse events Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v6.0.All Adverse Events (AEs) occurring during the clinical study period will be monitored.
Biodistribution
Time frame: Through study completion, assessed up to 2 years.
Evaluation of drug biodistribution in major human organs.
Radiation dosimetry
Time frame: Through study completion, assessed up to 2 years.
Standard uptake value (SUV).
Radiation dosimetry
Time frame: Through study completion, assessed up to 2 years.
Organ accumulation (%ID).
Radiation dosimetry
Time frame: Through study completion, assessed up to 2 years.
Absorbed dose (AD).
Radiation dosimetry
Time frame: Through study completion, assessed up to 2 years.
Effective dose (ED) in tumors and target organs.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: Through study completion, assessed up to 2 years.
Duration of Response (DOR)
Time frame: Through study completion, assessed up to 2 years.
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 14 Sep 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.
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-FAP-VG11 in people with Fibroblast Activation Protein (FAP)-Positive Advanced Solid Tumours, run by Shandong Cancer Hospital and Institute 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 10 inclusion and 8 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 14 Sep 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?
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 Xiaorong Sun (0531-67626287, xrsun@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLT) (time frame: Through study completion, assessed up to 2 years.). The study lists 8 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 Sep 2026.