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

Doctors:

Vasily J. Assikis MD

William S. Jonas MD

Eric D. Mininberg MD

Ha N. Tran MD

Rajni Sinha MD

Jay Rhee MD

Samantha Shams MD

Nikita Tushar Amin MD

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

Doctors:

Jonathan C. Bender MD

Trevor M. Feinstein MD

Vipin Ramprasad Lohiya MD

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

Doctors:

Vasily J. Assikis MD

Minesh D. Patel MD

Nikita Tushar Amin MD

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

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

Doctors:

Eric D. Mininberg MD

Ha N. Tran MD

Vipin Ramprasad Lohiya MD

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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.