ABSK061 / Abbisko - LARVOL DELTA

Phase II clinical trial of oral PD-L1 small molecule inhibitor ABSK043 combined with FGFR2/3 small molecule inhibitor ABSK061 for the treatment of solid tumors completed and the first gastric cancer patient was dosed [Google translation] (pharnexcloud.com) - "Heyu Pharmaceuticals...announced that it had completed the dosing of the first gastric cancer patient in an open-label multicenter Phase II clinical study evaluating the safety and efficacy of ABSK061 and ABSK043 with or without chemotherapy in patients with metastatic/unresectable solid tumors with FGFR2/3 alterations (Protocol number: ABSK061-201)....The dose escalation will evaluate the safety, tolerability, preliminary efficacy and PK characteristics of ABSK061+ABSK043 in patients with metastatic/unresectable advanced solid tumors with FGFR2/3 activation changes or overexpression, and recommend the dosage for the expansion phase."

Trial status • Gastric Cancer • Solid Tumor

A Phase 2 Clinical Study of ABSK061 and ABSK043 (clinicaltrials.gov) - P2 | N=202 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3 • HER-2

A Phase 2 Clinical Study of ABSK061 and ABSK043 (clinicaltrials.gov) - P2 | N=202 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

Metastases • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3 • HER-2

Novel FGFR2/3 inhibitor shows promise in solid tumors, including bladder cancer (Urology Times) - P1 | N=85 | NCT05244551 | Sponsor: Abbisko Therapeutics Co, Ltd | "Findings from a first-in-human phase 1 trial (NCT05244551) presented at the 2024 ESMO Targeted Anticancer Therapies Congress showed that the selective FGFR2/3 inhibitor ABSK061 is safe and induced anti-tumor activity in patients with advanced solid tumors—including urothelial carcinoma—harboring FGFR2/3 alterations. Results showed that patients evaluable for efficacy (n = 8) experienced an overall response rate (ORR) of 37.5%, which was comprised entirely of partial responses (PRs). The disease control rate (DCR) was 75%."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

First-in-human study of ABSK061: A selective fibroblast growth factor receptor (FGFR) 2/3 inhibitor for treating patients with advanced solid tumors (ESMO-TAT 2024) - P1 | "PR was observed in non-small cell lung cancer (FGFR2 fusion) and urothelial carcinoma (FGFR3 fusion). Conclusions This study demonstrated the anti-tumor activity of ABSK061 in patients with FGFR2/3 alterations and its favorable safety profile, which warrants further investigation."

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR • FGFR1 • FGFR2 • FGFR3

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2022 ➔ Jun 2022

Enrollment open • Trial initiation date • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

Abbisko Therapeutics Completed Dosing of First Patient for Its First-in-Class Highly Selective FGFR2/3 Inhibitor ABSK061 (PRNewswire) - "Abbisko Therapeutics Co., Ltd....announced completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally....The trial is currently being conducted in both China and US."

Trial status • Oncology • Solid Tumor

FGFR2/3 Inhibitor ABSK061 in Patients With Advanced Solid Tumors Phase I Study (clinicaltrials.gov) - P1 | N=85 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

New P1 trial • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2