RecruitingPhase 1NCT07141706

A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors


Sponsor

DualityBio Inc.

Enrollment

253 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called DB-1317 for people with advanced/metastatic solid tumors. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDB-1317

Administered I.V.


Locations(14)

USA04-0

Los Angeles, California, United States

USA05-0

Ann Arbor, Michigan, United States

Site USA06-0

Pittsburgh, Pennsylvania, United States

USA02-0

Houston, Texas, United States

USA03-0

San Antonio, Texas, United States

USA01-0

Fairfax, Virginia, United States

AUS03-0

Liverpool, New South Wales, Australia

AUS01-0

Randwick, New South Wales, Australia

AUS04-0

Westmead, New South Wales, Australia

AUS02-0

Nedlands, Western Australia, Australia

Chn01-1/Chn01-2

Guangzhou, Guangdong, China

CHN05-0

Harbin, Heilongjiang, China

CHN03-0

Zhengzhou, Henan, China

CHN04-0

Jinan, Shandong, China

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NCT07141706


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