cabotamig (ARB202) / Arbele - LARVOL DELTA

Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Arbele Pty Ltd | Trial completion date: Aug 2025 ➔ May 2026 | Trial primary completion date: Nov 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Liver Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • CDH17

Development of a cadherin-17 (CDH17) immunohistochemistry assay for use as a companion diagnostic for cabotamig in gastrointestinal cancers (ESMO 2024) - P1 | "TibDx1 CDH17 IHC assay is a validated and reliable companion diagnostic tool, which facilitates patient selection for the effective use of Cabotamig in GI cancers."

Companion diagnostic • Biliary Cancer • Cholangiocarcinoma • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Liver Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CDH17

Novel T-cell engager, CDH17 X CD3 cabotamig (ARB202) continues to explore dosing in patients with advanced gastrointestinal cancers (PRNewswire) - "Arbele...today announced the positive recommendation from the second meeting of the Data Monitoring Committee (DMC) to continue the A001 Phase I clinical trial evaluating cabotamig (ARB202) in patients with advanced gastrointestinal (GI) cancers without modification to the trial protocol....This safety assessment was based on the review of safety data from 18 patients, including patients that have been treated with multiple doses of cabotamig. This positive recommendation confirms tolerability profile of cabotamig is consistent with published safety data of T-cells engagers in other indications."

DSMB • Gastrointestinal Cancer • Oncology • Solid Tumor

Arbele announces early safety data for novel CDH17xCD3 bispecific T-cell engager at American Society of Clinical Oncology Breakthrough Meeting (PRNewswire) - P1a | N=68 | NCT05411133 | Sponsor: Arbele Pty Ltd | "Arbele...presented early safety data from its first-in-class CDH17xCD3 bispecific T-cell engager antibody, ARB202, at the ASCO Breakthrough conference in Yokohama, Japan. Preliminary data from Phase 1a study indicate ARB202 tolerability up to 150ng/ml Cmax in circulation, suggesting no clinically significant off-target T-cell activation at these levels. A total of ten (10) [6 colorectal carcinoma; 2 cholangiocarcinoma; 1 gastric cancer; 1 gastrointestinal adenocarcinoma] have completed dosing across the first 3 dose-level cohorts ranging from 0.0003 to 0.003 mg/kg by single IV doses....As of 29 Jun 2023, the safety review committee and an independent data monitoring committee, DMC, had approved the trial to continue without modification....Arbele intends to present more findings at an appropriate scientific meeting."

P1 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Arbele Announces Phase 1 First-in-Human Study of CDH17xCD3 Bispecific T-Cell Engager for Treatment of Gastrointestinal Cancers (PRNewswire) - "Arbele...announces the successful dosing of the first patient in Australia in Phase I Study of ARB202, for the treatment of advanced gastrointestinal cancers patients...The Phase I trial is a continuous multi-center, open-label, dose-escalation trial for both the ascending dose (Phase Ia) and dose ranging (Phase Ib/2a) phases (clinicaltrials.gov: NCT05411133), with aims to determine the tolerability and/or to be used dose of ARB202....Arbele expects to report initial safety, tolerability, and PK/PD data in 2Q 2023."

P1 data • PK/PD data • Trial status • Gastrointestinal Cancer • Oncology • Solid Tumor

Treatment of ARB202 Advanced Gastrointestinal Cancer Patients (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Arbele Pty Ltd

New P1 trial • Biliary Cancer • Cholangiocarcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Liver Cancer • Oncology • Pancreatic Cancer • Solid Tumor • IL2