A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT05150691
Trial Phases:	Phase I Phase II	Protocol IDs:	DB-1303-O-1001 (primary) NCI-2022-04237
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	DualityBio Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05150691

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Objectives

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9
cohorts), open-label, multiple-dose, 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 MTD/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
HER2-expressing malignant solid tumors.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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