SOCRA 2024 Annual Conference Program Book - Flipbook - Page 53
Conflict of Interest
• DSMC: Sotio
Trends in Phase 1 Clinical Trial Design
(Optimus Project)
• Research funding*: BridgeBio Pharma (Inst), Revolution Medicine (Inst), Quanta Therapeutics
(Inst), 280 Bio (Inst), Tango Therapeutics (Inst), Repare Therapeutics (Inst), Sumitomo (Inst), ABM
Therapeutics (Inst), BMS (Inst), Novartis (Inst), Bayer (Inst), GlaxoSmithKline (Inst), Pfizer (Inst),
MedImmune (Inst), Genentech (Inst)
• Consultant: Revolution Medicine, Lilly, Quanta Therapeutics, Jazz Pharmaceuticals, EcoR1 Capital,
Abbvie, Tolero, Guidepoint, Clearview Health Care Partners
Ignacio Garrido‐Laguna, MD, PhD
Professor GI Oncology
Director Phase 1 Program
Huntsman Cancer Institute, University of Utah (NCI‐CCC)
Salt Lake City, UT
* Research funding to my institution for my role as principal investigator in clinical trials
SOCRA Sept 27th 2024
Agenda
• Historical perspective of
phase 1 clinical trials
• High attrition rate
• Cytotoxic vs. novel drug
paradigms
• Project Optimus
• Impact on phase 1 design
• What’s next?
Horstmann et al. NEJM 2005
High Attrition Rate
Objective response
Metanalysis Phase 1 trials 2015‐18
158 trials (N=6707)
Molecularly targeted agents (MTA),
Immunomodulators and
antiangiogenic
Overall
6.4%
MTA
7.6%
Immunomodulator
6.7%
Antiangiogenic
0.9%
Biomarker Y/N
12 vs 4% (p
