๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

A Study of DM001 in Patients With Advanced Solid Tumors (NCT06475937)

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

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

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (ยฑ 7 days) after the End of Treatment visit.

Who can join: Review the eligibility criteria below.

Location: Sarah Cannon Research Institute (SCRI) โ€” Nashville, Tennessee

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 (5 Sites)

  • Sarah Cannon Research Institute (SCRI) โ€” Nashville, Tennessee
  • University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • Icon Cancer Centre South Brisbane โ€” South Brisbane, Queensland
  • Tasman Oncology Research โ€” Southport, Queensland
  • Monash Health โ€” Clayton, Victoria

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.

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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†—