BI 4060107 / Aimed Bio, Boehringer Ingelheim - LARVOL DELTA

A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours) (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: AIMEDBIO

First-in-human • New P1 trial • Oncology • Solid Tumor

Aimed Bio's Antibody-Drug Conjugate (ADC) new drug candidate "BI 4060107 (development code name ODS025)," which was licensed out to C. H. Boehringer Sohn AG & Co. KG, received approval for a phase 1 investigational new drug (IND) application in Japan. (Chosun Biz)

New P1 trial • Solid Tumor

AimedBio disclosed on July 15 that it had received approval from the French National Agency for Medicines and Health Products Safety (ANSM) for the Investigational New Drug (IND) application for a Phase 1 clinical trial of BI 4060107. [Google translation] (The Bio) - "The clinical trials will be conducted at 13 institutions across five countries. AimedBio received IND approval from the US Food and Drug Administration (FDA) and Korea's Ministry of Food and Drug Safety (MFDS) on June 26. The clinical trial of BI 4060107 is expected to continue for approximately 36 months from the date of IND approval, with completion anticipated on June 26, 2029."

New P1 trial • Solid Tumor

AimedBio…announced…that ODS025 (BI 4060107), an antibody-drug conjugate (ADC) cancer drug it licensed to Boehringer Ingelheim, has received Phase 1 clinical trial approval from the U.S. Food and Drug Administration (FDA). (Seoul Economic Daily) - "The trial aims to evaluate the safety, tolerability, and pharmacokinetics of intravenously administered ODS025 in patients with unresectable advanced or metastatic solid tumors, and to determine the drug's maximum tolerated dose (MTD) and recommended dose for expansion (RDE). The trial will be conducted at 13 institutions across five countries. It will involve approximately 90 patients over about three years. The primary endpoint is whether dose-limiting toxicity (DLT) occurs during the evaluation period...AimedBio will receive a milestone payment following this clinical trial approval."

IND • New P1 trial • Solid Tumor