๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-08

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (NCT05438329)

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: DualityBio Inc.

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

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.

Who can join: Review the eligibility criteria below.

Location: Site 139 โ€” Bullhead City, Arizona

Age range: 18 Years

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 (93 Sites)

Showing the first 25 of 93 sites.

  • Site 139 โ€” Bullhead City, Arizona
  • Site 103 โ€” Cerritos, California
  • Site 136 โ€” La Jolla, California
  • Site 127 โ€” Los Angeles, California
  • Site 133 โ€” Los Angeles, California
  • Site 108 โ€” Los Angeles, California
  • Site 131 โ€” Washington D.C., District of Columbia
  • Site 122 โ€” Coral Springs, Florida
  • Site 142 โ€” Hialeah, Florida
  • Site 114 โ€” Margate, Florida
  • Site 120 โ€” Miami, Florida
  • Site 126 โ€” Ocala, Florida
  • Site 140 โ€” Orange City, Florida
  • Site 109 โ€” Plantation, Florida
  • Site 141 โ€” St. Petersburg, Florida
  • Site 117 โ€” Tamarac, Florida
  • Site 111 โ€” Honolulu, Hawaii
  • Site 134 โ€” Chicago, Illinois
  • Site 124 โ€” Dearborn, Michigan
  • Site 106 โ€” Detroit, Michigan
  • Site 125 โ€” Royal Oak, Michigan
  • Site 129 โ€” Las Vegas, Nevada
  • Site 160 โ€” Mineola, New York
  • Site 116 โ€” New York, New York
  • Site 102 โ€” New York, New York

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. Review the official NIH record below to find the coordinating site.
  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†—