Clinical Evaluation of 177Lu-FAP-VG11 Injection in Patients With Fibroblast Activation Protein -Positive Advanced Solid Tumours

NCT07808177 | Recruiting Early Phase 1

• 1 other identifier: SDZLEC2026-049-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroblast Activation Protein (FAP)-Positive Advanced Solid Tumours

Outcome Measures

Primary Outcomes (8)

• Dose-Limiting Toxicities (DLT)

  Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.

  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.

  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.

  Through study completion, assessed up to 2 years.

• Biodistribution

  Evaluation of drug biodistribution in major human organs.

  Through study completion, assessed up to 2 years.

• Radiation dosimetry

  Standard uptake value (SUV).

  Through study completion, assessed up to 2 years.

• Radiation dosimetry

  Organ accumulation (%ID).

  Through study completion, assessed up to 2 years.

• Radiation dosimetry

  Absorbed dose (AD).

  Through study completion, assessed up to 2 years.

• Radiation dosimetry

  Effective dose (ED) in tumors and target organs.

  Through study completion, assessed up to 2 years.

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  Through study completion, assessed up to 2 years.

• Duration of Response (DOR)

  Through study completion, assessed up to 2 years.

Study Arms (1)

177Lu-FAP-VG11 injection treatment

EXPERIMENTAL

Patients will be treated with 177Lu-FAP-VG11 Injection

Drug: 177Lu-FAP-VG11

Interventions

177Lu-FAP-VG11 DRUG

Patients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose.

177Lu-FAP-VG11 injection treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

Central Study Contacts

Xiaorong Sun

CONTACT

0531-67626287; xrsun@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 8, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2029
• Last Updated: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)