XCancer

Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors

Description:

This is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer. The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. The study will also assess its in vivo biodistribution, radiation absorbed dose in normal organs and target lesions, and preliminary clinical efficacy. The main question this study aims to answer is whether ¹⁷⁷Lu-CTR-FAPI can be administered safely and shows sufficient tumor-targeting and preliminary therapeutic activity to support further clinical investigation in patients with FAP-high expressing metastatic solid tumors.

Sponsor:

Nantes University Hospital

Phase:

Early Phase 1

Government Study Link:

NCT07587996 - Click here to see study on

ClinicalTrials.gov

CTR-FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Inclusion
  • There is at least one measurable lesion (RECIST 1.1)
  • 68Ga-CTR-FAPI PET/CT confirmed high expression of FAP in the tumor (more than 50% of the lesions with SUVmax ≥ 10)
  • ECOG score: 0 - 2
  • Organ/marrow functions meet the specified thresholds, and there are no severe electrocardiogram abnormalities (QTcF ≤ 470ms)
Exclusion
  • There is brain metastasis or other central nervous system lesions.
  • Within 4 weeks before administration, the patient has received chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments or investigational drugs.