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: Laura Palazzolo, Christina Grace Wilson, Leslie R Boyd, Kent Chan, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Carol M Lee, Edward A Jimenez, Erin Annette Reese, Jonathan B Kahn, Gabrielle Fridman, Fabia Brisard Pierrot, Cindy Corbo, Whitfield B. Growdon, Nitish Mehta, Deanna Gerber, Caitlin Elizabeth Ryan, Marina Stasenko, Kelly A Levine, Olivia Richardson Khouri, Kathleen M Lutz.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.