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: Stomach, Small Intestine, Rectum, Anus, Pancreas, Other Digestive Organ, Lung, Other Respiratory and Intrathoracic Organs, Soft Tissue, Other Skin, Ovary, Other Female Genital, Prostate, Other Urinary, Thyroid, Bladder, Breast, Melanoma, Skin
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.