MGC030 / MacroGenics - LARVOL DELTA

A Study of MGC030 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=314 | Not yet recruiting | Sponsor: MacroGenics

First-in-human • New P1 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

Anticipated Milestones:…MGC030 (GlobeNewswire) - "MGC030 is a first-in-class preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for the third quarter of 2026."

IND • Solid Tumor

Key Strategic Priorities for 2025 and 2026 (Macrogenics Press Release) - "Determine development path for lorigerlimab based on data from the ongoing LORIKEET and LINNET studies. Advance MGC026 and MGC028 programs to assess clinical proof-of-concept. Submit Investigational New Drug (IND) application for MGC030. Initiate IND-enabling studies for two new product candidates. Forge partnerships and collaborations to accelerate development of the Company’s proprietary product candidates and technology platforms."

IND • M&A • Preclinical • Oncology

MacroGenics Provides Update on Corporate Progress and First Quarter 2025 Financial Results (Macrogenics Press Release) - "First patient dosed in LINNET Phase 2 study of lorigerlimab in ovarian and other gynecologic cancers; Clinical update on LORIKEET, a randomized 150-patient Phase 2 study of lorigerlimab in combination with docetaxel in patients with mCRPC, expected in second half of 2025...MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in 2025; An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026."

IND • P2 data • Trial status • Castration-Resistant Prostate Cancer • Ovarian Cancer

MacroGenics Provides Update on Corporate Progress and 2024 Financial Results (GlobeNewswire) - "Emerging ADC Pipeline:...(i) MGC026:...MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in 2025; (ii) MGC028:...The first patient was recently dosed in a Phase 1 study of MGC028 in patients with advanced solid tumors; (iii) MGC030:...An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026."

IND • Trial status • Solid Tumor