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177Lu-JH04 in Patients with FAP-Positive Tumors

NCT06636617 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-10

No results posted yet for this study

Summary

This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.

Conditions

  • Patients with Advanced Metastatic FAP-Positive Tumors

Interventions

DRUG

3.70 GBq (100 mCi) of 177Lu-JH04

All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.

DRUG

5.55 GBq (150 mCi) of 177Lu-JH04

All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04

DRUG

7.40 GBq (200 mCi) of 177Lu-JH04

All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04

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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-08-21
Primary Completion
2025-08-31
Completion
2025-08-31

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 NCT06636617 on ClinicalTrials.gov