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, Caitlin Elizabeth Ryan, Kathleen M Lutz, 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, Alexander A Hindenburg.


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