GWN323 / Novartis - LARVOL DELTA

Model-informed drug development for immuno-oncology agonistic anti-GITR antibody GWN323: dose selection based on MABEL and biologically active dose. (PubMed, Clin Transl Sci) - "GWN323 PK from the FIH study was described by a population PK model; the relationship with ex vivo interleukin-2 release, a target-engagement marker, was also modeled. The clinical PK/PD modeling data supported the biological active dose projected from the translational PK/PD modeling in a "learn and confirm" paradigm of model-informed drug development of GWN323."

IO biomarker • Journal • Colon Cancer • Oncology • IL2

First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. (PubMed, J Immunother Cancer) - P1 | "GWN323, as a single agent and in combination, was well tolerated in patients with relapsed/refractory solid tumors. The MAD was 1500 mg q3w for single-agent and GWN323 750 mg+spartalizumab 300 mg q3w for combination treatments. Minimal single-agent activity and modest clinical benefit were observed with the spartalizumab combination."

Clinical • Combination therapy • IO biomarker • Journal • P1 data • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Rectal Cancer • Respiratory Diseases • Solid Tumor • CD8 • IFNG • TNFA

Phase I/Ib study of GWN323 alone and in combination with PDR001 in patients with advanced malignancies and lymphomas (clinicaltrials.gov) - Ambassador: Jason J. Luke; P1, N=264; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial primary completion date: Jan 2019 ➔ May 2019. 

Trial primary completion date • Melanoma KOL Tracker

Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas (clinicaltrials.gov) - P1; N=92; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas (clinicaltrials.gov) - P1; N=92; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Nov 2019 ➔ Apr 2020; Trial primary completion date: Nov 2019 ➔ Apr 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date

Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas (clinicaltrials.gov) - P1; N=92; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting ➔ Active, not recruiting; N=264 ➔ 92

Clinical • Combination therapy • Enrollment change • Enrollment closed