AbGn-107 / AltruBio - LARVOL DELTA

A multicenter phase Ia study of AbGn-107, a novel antibody-drug conjugate, in patients with advanced gastrointestinal cancer. (PubMed, Invest New Drugs) - P1 | "Further evaluation is required to assess the clinical validity of AG-7 as a suitable antigen for therapeutic targeting. Clinical Trial information: NCT02908451."

Journal • Metastases • P1 data • Biliary Cancer • Cardiovascular • Colorectal Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Hepatology • Infectious Disease • Oncology • Pain • Pancreatic Cancer • Solid Tumor

Phase Ia, first-in-human study of AbGn-107, a novel antibody-drug conjugate (ADC), in patients with gastric, colorectal, pancreatic, or biliary cancers. (ASCO-GI 2020) - P1; "Overall, AbGn-107 appears well-tolerated with encouraging prelim signs of efficacy (prolonged dz control) in non-biomarker selected pts with advanced GI cancers. Pre-screening for high AG-7 expression is underway for subjects with G, CRC, PDA, and BIL cancers for the cohort expansion phase of this study, which will be open across multiple sites in U.S. and Taiwan. Clinical trial information: NCT02908451."

Clinical • P1 data • Biliary Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

[VIRTUAL] Phase I, first-in-human study of AbGn-107, a novel antibody-drug conjugate (ADC), in patients with gastric, colorectal, pancreatic or biliary cancers. (ASCO 2020) - "Overall, AbGn-107 appears well-tolerated with encouraging prelim signs of efficacy in unselected pts with heavily pre-treated advanced GI cancers. Updated safety and efficacy data will be provided at the time of the meeting for the cohort expansion phase of this study (currently open across multiple sites in U.S. and Taiwan), in which subjects with G, CRC, PDA, and BIL cancers are pre-screened for high levels of AG-7 tumor expression. Research Funding: Abgenomics"

Clinical • P1 data • Biliary Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer (clinicaltrials.gov) - P1; N=39; Terminated; Sponsor: AbGenomics B.V Taiwan Branch; N=136 ➔ 39; Active, not recruiting ➔ Terminated; Trial primary completion date: Oct 2020 ➔ Feb 2021; COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.

Clinical • Enrollment change • Trial primary completion date • Trial termination • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

AMG 510, AbGn-107 Prove to Be Effective, Tolerable in GI Cancers (OncLive) - P1. N=42; "Andrew L. Coveler, MD, discusses the early-phase data with AMG 510 and AbGn-107 in gastrointestinal malignancies....For AMG 510, there is a robust developmental path of trying that drug in combination with other agents. Moving forward, a lot of that is somewhat available on Clinicaltrials.gov to see what future combinations are available. [AbGn-107], which had minor responses for 6 patients, had patients with pancreas cancer who experienced durable disease control for longer than expected and will potentially be seen in the future with combination studies."

P1 data

"AMG 510, AbGn-107 Prove to Be Effective, Tolerable in GI Cancers https://t.co/c93XcESshN via @onclive" (@sheik2411)

Gastric Cancer • Gastrointestinal Cancer • Oncology

"AMG 510, AbGn-107 Prove to Be Effective, Tolerable in GI Cancers @SeattleCCA #hpbcsm https://t.co/thc8AeosbK" (@OncLive)

Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer (clinicaltrials.gov) - P1; N=136; Active, not recruiting; Sponsor: AbGenomics B.V Taiwan Branch; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gall Bladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

AltruBio Inc. presented AbGn-107 Phase 1a chemo-refractory GI cancer results at ASCO-GI 2020 (PRWeb) - P1a, N=136; NCT02908451; Sponsor: AbGenomics B.V Taiwan Branch; "AbGn-107 showed a well-tolerated safety profile and acceptable PK profile, as well as preliminary signs of efficacy including several patients with prolonged disease control. The ongoing cohort expansion phase was initiated focusing on enrollment of patients with high expression of this glycoepitope target to further evaluate the safety and efficacy of this ADC."

P1 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer