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

Sponsor:

Dualitybio, Inc.

Sponsor Study ID:

DB-1311-O-1001

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.

eConsent:

Not available

Study Documents:

Open Study Documents
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