lavengratinib (ABSK061) / Abbisko - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Abbisko Therapeutics Co, Ltd | Trial completion date: Nov 2025 ➔ Apr 2026 | Recruiting ➔ Completed

Trial completion • Trial completion date

Phase II study of ABSK061 (selective FGFR2/3 inhibitor) combined with ABSK043 (oral PD-L1 inhibitor) ± CAPOX in advanced FGFR2-positive gastric cancer and gastroesophageal junction cancer (GC/GEJC): Preliminary results from ABSK061-201. (ASCO 2026) - P2 | "ABSK061 combined with ABSK043, with or without CAPOX, has demonstrated a manageable safety profile and encouraging anti-tumor activity in both 1L and 2L+ FGFR2-positive GC/GEJC. These promising results warrant further clinical development of the doublet and quadruplet regimens for GC/GEJC."

IO biomarker • Metastases • P2 data • Dental Disorders • Gastric Cancer • Oncology • Solid Tumor • Stomatitis • FGFR2 • HER-2

Circulating tumor DNA (ctDNA)-based profiling of acquired resistance to the fibroblast growth factor receptor (FGFR)2/3 inhibitor lavengratinib(ABSK061) in patient(pt)s with advanced solid tumors (AACR 2026) - P1 | "This study revealed diverse genomic mechanisms imparting acquired resistance to the selective FGFR2/3 Inhibitor lavengratinib, including secondary FGFR2/3 kinase domain mutations as well as off-target alterations in RTK/RAS and DDR pathways. In GC and CCA, polyclonal FGFR2 acquired mutations represent a convergent, on-target resistance mechanism to FGFR inhibition. These findings provide molecular insights into resistance mechanisms and guide the combination and sequential therapy strategies to overcome resistance in FGFR2/3 driven advanced solid tumors."

Circulating tumor DNA • Clinical • Metastases • Preclinical • Biliary Cancer • Cervical Cancer • Cholangiocarcinoma • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3

Abbisko Therapeutics' FGFR2/3 Inhibitor ABSK061 Receives FDA IND Clearance for Achondroplasia in Children (The Manila Times) - "ABSK061 is currently being evaluated in a Phase II clinical trial for ACH, and in December 2025, the study dosed its first patient in China. Preliminary data are expected to be reported in the second half of 2026. As an important part in the global development strategy for ABSK061, Abbisko plans to enroll US patients into the Phase II study to further evaluate safety, tolerability, and efficacy of ABSK061 for the treatment of ACH."

Enrollment status • IND • Genetic Disorders

Abbisko Therapeutics…announced that six preclinical study updates from its proprietary pipeline have been selected for poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting (Abbisko Therap Press Release)

Preclinical • Solid Tumor

Abbisko’s unit secured FDA Orphan Drug status for ABSK061, an oral FGFR2/3 inhibitor targeting pediatric achondroplasia (TipRanks) - "The candidate, designed to address aberrant FGFR3 activation underlying the rare genetic growth disorder, is in a Phase II trial in children aged three to twelve, with initial data expected in the second half of 2026."

Orphan drug • Rare Diseases

…Abbisko Therapeutics…announced that its independently developed, highly selective, oral small-molecule FGFR2/3 inhibitor ABSK061, has been granted Rare Pediatric Disease ('RPD') designation by the U.S.Food and Drug Administration ('FDA') for the treatment of achondroplasia ('ACH') (HKEXnews)

FDA event • Genetic Disorders

A Study of ABSK061 to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy in Children With Achondroplasia (clinicaltrials.gov) - P1/2 | N=110 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

New P1/2 trial • Genetic Disorders

A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Abbisko Therapeutics Co, Ltd | Recruiting ➔ Completed | N=73 ➔ 40 | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Next-generation isoform-selective fibroblast growth factor receptor inhibitors. (PubMed, Trends Pharmacol Sci) - "Pan-FGFR-selective inhibitors (erdafitinib, pemigatinib, and futibatinib) have been developed in clinical practice...FGFR2-selective inhibitor lirafugratinib, FGFR3-selective inhibitors LOXO-435 and TYRA-300, FGFR2/3-selective inhibitor ABSK061, and FGFR4-selective inhibitors are in clinical development. Additionally, novel isoform-selective FGFR-targeting degraders, FGFR2b/FGFR3-selective antibodies, and de novo-designed 'c' isoform-selective proteins provide novel treatment strategies. This review provides an overview of the current FGFR-targeted therapeutics and limitations and evaluates next-generation inhibitor development to guide future research."

Journal • Review • Oncology • FGFR • FGFR2 • FGFR3 • FGFR4

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

New P1 trial

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