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RECRUITING
NCT07141706
PHASE1

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

Sponsor: DualityBio Inc.

View on ClinicalTrials.gov

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 up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

233

Start Date

2025-09-23

Completion Date

2028-06

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

DB-1317

Administered I.V.

Locations (6)

USA04-0

Los Angeles, California, United States

Site USA06-0

Pittsburgh, Pennsylvania, United States

USA02-0

Houston, Texas, United States

USA03-0

San Antonio, Texas, United States

USA01

Fairfax, Virginia, United States

AUS01-0

Randwick, New South Wales, Australia