Abbisko Cayman Limited has announced the initiation of a Phase II clinical trial to investigate the efficacy and safety of its investigational oral drugs, ABSK061 and ABSK043, in patients with metastatic or unresectable solid tumors characterized by FGFR2/3 alterations. The trial marks a crucial phase in the development of these agents, which have previously demonstrated encouraging anti-tumor activity and a favorable safety profile in earlier studies.
The Phase II trial aims to further evaluate the potential of ABSK061 and ABSK043 as targeted therapies for cancers driven by specific FGFR alterations. These alterations, present in a subset of solid tumors, can lead to uncontrolled cell growth and proliferation. By selectively inhibiting FGFR2 and FGFR3, these drugs aim to disrupt these oncogenic signaling pathways and induce tumor regression.
Trial Design and Objectives
The Phase II trial is designed as an open-label, multi-center study. Patients with advanced solid tumors harboring documented FGFR2 or FGFR3 alterations are eligible for enrollment. The primary endpoint of the trial is to assess the objective response rate (ORR) according to RECIST 1.1 criteria. Secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.
ABSK061 and ABSK043: Targeting FGFR2/3
ABSK061 and ABSK043 are orally bioavailable, selective inhibitors of FGFR2 and FGFR3, respectively. These kinases play a critical role in cell signaling pathways that regulate cell growth, differentiation, and survival. Aberrant activation of FGFR2 and FGFR3 has been implicated in the pathogenesis of various cancers, making them attractive therapeutic targets.
Clinical Significance
The initiation of this Phase II trial represents a significant milestone in the development of ABSK061 and ABSK043. If successful, these agents could provide a new treatment option for patients with advanced solid tumors harboring FGFR2/3 alterations, addressing an unmet medical need in this patient population. Further updates on the trial's progress are anticipated as the study progresses.
