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Clinical Study of 177Lu-JH040182 in Patients With FAP-Positive Malignancies

NCT07681141 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-07-02

No results posted yet for this study

Summary

This first-in-human study aimed to assess the safety and internal radiation dosimetry of 177Lu-JH040182, a novel FAP-targeted radiopharmaceutical, in patients with FAP-positive tumors. All patients underwent screening via 68Ga-FAPI PET/CT. Those confirmed to have FAP-positive lesions on PET imaging received administration of 177Lu-JH040182, and serial-time-point SPECT images were acquired for internal radiation dosimetry calculations.

Conditions

  • Patients With Advanced Metastatic FAP-Positive Tumors

Interventions

DRUG

177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq

Subjects will receive intravenous administration of 177Lu-JH040182 at an activity of approximately 5.55-7.50 GBq.

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Weibing Miao, MD · The First Affiliated Hospital, Fujian Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07681141 on ClinicalTrials.gov