A Study of DB-1310 in Advanced/Metastatic Solid Tumors

Active:	Yes
Cancer Type:	Breast Cancer Head and Neck Cancer Lung Cancer Solid Tumor Unknown Primary	NCT ID:	NCT05785741
Trial Phases:	Phase I Phase II	Protocol IDs:	DB-1310-O-1001 (primary) NCI-2023-06649 CTR20231736
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	DualityBio Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05785741

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1310 in subjects with advanced solid tumors.

Objectives

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts
the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the
RCD_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and
the RCD_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase
to confirm the safety, tolerability and explore efficacy in selected malignant solid
tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved
trastuzumab biosimilar or in combination with Osimertinib.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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