First-in-Human Study of ABY-029, a Novel Fluorescent Peptide that Targets EGFR, Applied to Soft-Tissue Sarcomas.

ABSTRACT: ABY-029, an anti-EGFR Affibody molecule conjugated to IRDye 800CW, recently underwent first-in-human testing in soft-tissue sarcoma. The FDA Exploratory Investigational New Drug status was obtained for the phase 0 clinical trial in which study objectives were to determine whether a biological variance ratio (BVR) of 10 was achievable, whether fluorescence intensity correlated with EGFR expression, and whether doses were well tolerated. Patients (N = 12) with soft-tissue sarcoma were recruited based on positive EGFR IHC staining of diagnostic biopsies. ABY-029 was administered at a microdose (30 nmol, n = 3), medium dose (90 nmol, n = 3), or high dose (171 nmol, n = 6) 1 to 3 hours prior to surgery. Following tumor resection, ex vivo tissue was imaged to determine the mean fluorescence inte

SUBMITTER: Samkoe KS 

PROVIDER: S-EPMC12312686 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature