๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-24

A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors (NCT07141706)

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

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: DualityBio Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: USA04-0 โ€” Los Angeles, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (14 Sites)

  • USA04-0 โ€” Los Angeles, California
  • USA05-0 โ€” Ann Arbor, Michigan
  • Site USA06-0 โ€” Pittsburgh, Pennsylvania
  • USA02-0 โ€” Houston, Texas
  • USA03-0 โ€” San Antonio, Texas
  • USA01-0 โ€” Fairfax, Virginia
  • AUS03-0 โ€” Liverpool, New South Wales
  • AUS01-0 โ€” Randwick, New South Wales
  • AUS04-0 โ€” Westmead, New South Wales
  • AUS02-0 โ€” Nedlands, Western Australia
  • Chn01-1/Chn01-2 โ€” Guangzhou, Guangdong
  • CHN05-0 โ€” Harbin, Heilongjiang
  • CHN03-0 โ€” Zhengzhou, Henan
  • CHN04-0 โ€” Jinan, Shandong

๐Ÿ“ž Contact the Study Coordinator

Phone: 01067228087

Email: junhua.gao@dualitybiologics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—