177Lu-JH04 in Patients with FAP-Positive Tumors

October 9, 2024 updated by: First Affiliated Hospital of Fujian Medical University

Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:
        • Contact:
          • Weibing Miao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • progressive advanced metastatic tumors
  • tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT
  • adequate renal, haematological, and liver function
  • an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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.
Experimental: 5.55 GBq (150 mCi) of 177Lu-JH04
All 3 patients were intravenous injected with single dose 5.55 GBq (150 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
Experimental: 7.40 GBq (200 mCi) of 177Lu-JH04
All 3 patients were intravenous injected with single dose 7.40 GBq (200 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxic and side effect
Time Frame: through study completion, an average of 2 weeks
The white blood cell count, granulocyte count, platelet count, hemoglobin count and serum biochemicals of each patient before and after each treatment were recorded and compared. And the weight (in kilograms) of the patients was monitored. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry of normal organs and tumors
Time Frame: through study completion, an average of 4 weeks
The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-JH04. The dose delivered to normal organs and tumors will be recorded.
through study completion, an average of 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response
Time Frame: through study completion, an average of 3 months
The number and size (long diameter in centimeter) of tumors were calculated and compared based on enhanced CT and MRI. The treatment effect of tumors was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Investigators

  • Principal Investigator: Weibing Miao, MD, the First Affiliated Hospital, Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstAHFujian-177Lu-JH04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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