Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636617
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
177Lu-JH04 in Patients with FAP-Positive Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PETCT for selection and were successively divided into three groups of 3 people eachThe three groups received successively an approximately 370 GBq 100 mCi 555 GBq 150 mCi and 740 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 tumorsamp 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None