A Phase 1/2a Multicenter Open-Label First in Human Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors
Brief description of study
This is a multicenter, non-randomized, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.
Clinical Study Identifier: s23-01065
ClinicalTrials.gov Identifier: NCT05438329
Principal Investigator:
Bhavana Pothuri.
Other Investigators:
Kent Chan,
Cindy Corbo,
Nitish Mehta,
Deanna Gerber,
Olivia Richardson Khouri,
Sarah Saerohm Lee,
Laura Palazzolo,
Marina Stasenko,
Jonathan B Kahn,
Fabia Brisard Pierrot,
Alexander A Hindenburg,
Caitlin Elizabeth Ryan,
Leslie R Boyd,
Christina Grace Wilson,
Michelle Diane Swanson Lightfoot,
Emeline Mariam Aviki,
Carol M Lee,
Whitfield B. Growdon,
Victoria Helen Dowd,
Edward A Jimenez,
Erin Annette Reese,
Gabrielle Fridman,
Kelly A Levine,
Kathleen M Lutz.
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