DB-1324 / GSK, DualityBio - LARVOL DELTA

A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors (clinicaltrials.gov) - P1/2 | N=127 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Gastrointestinal Cancer • Oncology • Solid Tumor • CDH17

A phase 1/2, first-in-human study of an ADC targeting CDH17 (DB-1324) in participants with advanced/metastatic gastrointestinal tumor (AACR 2026) - P1/2 | "The study plans to enroll approximately 127 participants in Phase 1 Dose Escalation and Backfill parts from locations including but not limited to Australia, United States and China. The study is currently open in multiple centers and is currently recruiting."

ADC • First-in-human • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Solid Tumor • CDH17

A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors (clinicaltrials.gov) - P1/2 | N=127 | Not yet recruiting | Sponsor: DualityBio Inc.

First-in-human • New P1/2 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

Duality Biologics and GSK Enter Exclusive Option Agreement for a Novel Antibody-drug Conjugate (DB-1324) (PRNewswire) - "Under the agreement, DualityBio will grant GSK an exclusive option to obtain a license to develop and commercialize DB-1324 worldwide (excluding mainland China, Hong Kong, and Macau)....The molecule, currently in preclinical development, leverages DualityBio's DITAC platform against a gastrointestinal (GI) cancer target....Under the terms of the agreement, GSK will pay $30 million upfront and additional pre-option milestone payments to obtain an exclusive option for exclusive worldwide rights for DualityBio's ADC (excluding China's mainland, Hong Kong, and Macau). Upon GSK exercising the Option, DualityBio will receive an option exercise fee as well as potential development, regulatory and commercial milestone payments totalling up to $975 million."

Licensing / partnership • Gastrointestinal Cancer