An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection
H Saber, P Del Valle, TK Ricks, JK Leighton - Regulatory Toxicology and …, 2017 - Elsevier
We retrospectively examined the nonclinical studies conducted with 17 CD3 bispecific
constructs in support of first-in-human (FIH) trials in oncology. We also collected information
on the design of dose-finding clinical trials. Sponsors have used different MABEL
approaches for FIH dose selection. To better assess acceptable approaches, FIH doses
were computed from nonclinical studies and compared to the maximum tolerated doses
(MTDs) in patients, to the highest human doses (HHDs) when an MTD was not identified, or …
constructs in support of first-in-human (FIH) trials in oncology. We also collected information
on the design of dose-finding clinical trials. Sponsors have used different MABEL
approaches for FIH dose selection. To better assess acceptable approaches, FIH doses
were computed from nonclinical studies and compared to the maximum tolerated doses
(MTDs) in patients, to the highest human doses (HHDs) when an MTD was not identified, or …
