Sponsor: Dualitybio, Inc.
Sponsor Study ID: DB-1311-O-1001
Study Title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors
CTO #: 103974
NCT Number: NCT05914116
Phase: I/II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Anus, Bladder, Breast, Lung, Melanoma, Skin, Other Digestive Organ, Other Female Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid
Study Objectives: This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311 as monotherapy.