lucorafusp alfa (AK130) / Akesobio - LARVOL DELTA

A phase 1b/2 study of AK130 (TIGIT/TGF-β bispecific fusion protein) combined with ivonescimab in advanced biliary tract cancer (BTC). (ASCO 2026) - P1/2 | "AK130 plus ivonescimab demonstrated potential anti-tumor activity with a manageable safety profile as a post-line option for advanced BTC, supporting its further development in this setting."

Bispecific • IO biomarker • Metastases • P1/2 data • Atopic Dermatitis • Biliary Cancer • Biliary Tract Cancer • Dermatitis • Immunology • Oncology • Solid Tumor • FGFR2 • HER-2 • IDH1 • PD-1 • TGFB1 • TIGIT

A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer (clinicaltrials.gov) - P1/2 | N=135 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Akeso Announces First Patient Dosed in Registrational Phase II Study of TIGIT/TGF-β Bifunctional Antibody Fusion Protein AK130 Combined with Ivonescimab for Advanced Pancreatic Cancer (PRNewswire) - "The initiation of the AK130-202 study marks a significant milestone in Akeso's strategy approach of 'IO2.0 + IO2.0' combinations."

Trial status • Pancreatic Cancer

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer (clinicaltrials.gov) - P1/2 | N=135 | Not yet recruiting | Sponsor: Akeso

New P1/2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

A Phase Ib/II Study of AK112 (PD-1/VEGF Bispecific Antibody) in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC). (clinicaltrials.gov) - P1/2 | N=280 | Not yet recruiting | Sponsor: Akeso

Combination therapy • Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of AK130 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Akeso | Not yet recruiting ➔ Completed | N=72 ➔ 19 | Trial completion date: Jan 2025 ➔ May 2024

Enrollment change • Metastases • Trial completion • Trial completion date • Oncology • Solid Tumor

A Study of AK130 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Akeso

Metastases • New P1 trial • Oncology • Solid Tumor

First and only TIGIT/TGF-β dual-targeting antibody fusion protein of Akeso demonstrated promise in preclinical results published at ESMO (PRNewswire) - "The encouraging observations from preclinical results of AK130 supports its clinical development for the treatment of human cancers: AK130 could specifically bind to human TIGIT and TGF-β with high affinity. In reporter gene assays, AK130 efficiently blocked the interaction between TIGIT and CD155, as well as TGF-β1/TGF-β3 and TGFβ-RII. As expected, AK130 did not show ADCC or CDC activity compared to tiragolumab. AK130 shows great anti-tumor efficacy in a mouse tumor model."

Preclinical • Oncology