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

NCT07681141 | Active Not Recruiting Phase 1

• 1 other identifier: FirstAHFujian-177Lu-JH040182
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fibroblast activation protein; lutetium-177

Outcome Measures

Primary Outcomes (1)

• Toxic and side effect

  The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

  From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)

Secondary Outcomes (1)

• Dosimetry of normal organs and tumors

  through study completion, an average of 4 weeks

Study Arms (1)

Intravenous administration of 177Lu-JH040182

EXPERIMENTAL

It is planned to recruit 3 subjects with FAP-positive tumors for administration of 177Lu-JH040182 at a dose ranging from 5.55 to 7.50 GBq.

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

Interventions

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

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

Intravenous administration of 177Lu-JH040182

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• progressive advanced metastatic tumors
• tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of tumor lesions)
• an Eastern Cooperative Oncology Group performance status of 0-2

You may not qualify if:

• pregnant or lactating women
• received other radionuclide therapy in the past 6 months
• received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Study Officials

• Weibing Miao, MD

  The First Affiliated Hospital, Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

CN (1)