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NCT Number: NCT06636617

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.

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Key information

Conditions

Patients With Advanced Metastatic FAP-Positive Tumors Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3.70 GBq (100 mCi) of 177Lu-JH04

Drug

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

5.55 GBq (150 mCi) of 177Lu-JH04

Drug

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

7.40 GBq (200 mCi) of 177Lu-JH04

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guochang Wang, MD

CONTACT

[email protected]

+86-0591-87981619

Weibing Miao, MD

CONTACT

[email protected]

+86-0591-87981618

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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