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

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.

Study Overview

• Status: Recruiting
• Conditions: Fibroblast Activation Protein (FAP)-Positive Advanced Solid Tumours
• Intervention / Treatment: Drug: 177Lu-FAP-VG11

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 Type: Interventional
• Enrollment (Estimated): 7
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiaorong Sun; Phone Number: 0531-67626287; Email: xrsun@sdfmu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Cancer Hospital of Shandong First Medical University
      • Contact: Xiaorong Sun; Phone Number: 0531-67626287; Email: xrsun@sdfmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 177Lu-FAP-VG11 injection treatment; Patients will be treated with 177Lu-FAP-VG11 Injection	Drug: 177Lu-FAP-VG11; Patients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Through study completion, assessed up to 2 years.

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2026
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2029

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: September 6, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SDZLEC2026-049-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No