A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

Active:	Yes
Cancer Type:	Liver Cancer / Hepatoblastoma Lung Cancer Melanoma	NCT ID:	NCT05914116
Trial Phases:	Phase I Phase II	Protocol IDs:	DB-1311-O-1001 (primary) NCI-2024-01206
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	DualityBio Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05914116

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

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 (maximum tolerated dose) and/or RP2D(Recommended Phase 2 Dose). Phase 2a is a
dose expansion phase to confirm the safety, tolerability and explore efficacy in selected
malignant solid tumors treated with DB-1311/BNT324 as monotherapy. And the
drug-drug-interaction (DDI) sub-study to evaluate the effect of lopinavir/ritonavir and
itraconazole on the PK of DB-1311 and its payload.

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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