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Trial Title:
177Lu-JH04 in Patients with FAP-Positive Tumors
NCT ID:
NCT06636617
Condition:
Patients with Advanced Metastatic FAP-Positive Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Lu-177
FAP
Tumor
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
3.70 GBq (100 mCi) of 177Lu-JH04
Description:
All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of
177Lu-JH04.
Arm group label:
3.70 GBq (100 mCi) of 177Lu-JH04
Intervention type:
Drug
Intervention name:
5.55 GBq (150 mCi) of 177Lu-JH04
Description:
All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04
Arm group label:
5.55 GBq (150 mCi) of 177Lu-JH04
Intervention type:
Drug
Intervention name:
7.40 GBq (200 mCi) of 177Lu-JH04
Description:
All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04
Arm group label:
7.40 GBq (200 mCi) of 177Lu-JH04
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
+86-0591 87981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Guochang Wang, MD
Phone:
+86-0591 87981619
Email:
guochang1007@163.com
Contact backup:
Last name:
Weibing Miao, MD
Start date:
August 21, 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636617
