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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

Piedmont Cancer Institute - Atlanta
1800 Howell Mill Road
Suite 800
Atlanta, GA 30318
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Fayetteville
1267 Highway 54 West
Suite 4200
Fayetteville, GA 30214
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Newnan
775 Poplar Road
Suite 310
Newnan, GA 30265
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute – Sandy Springs
Piedmont Cancer Institute – Sandy Springs
755 Mount Vernon Hwy
Suite 320
Atlanta, GA 30328




Piedmont Cancer Institute - Stockbridge
290 Country Club Drive
Suite 100
Stockbridge, GA 30281
678-298-3238
www.piedmontcancerinstitute.com



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

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