๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-04

IKS014 in Advanced Solid Tumors That Express HER2 (NCT05872295)

A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Iksuda Therapeutics Ltd.

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

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

Who can join: Review the eligibility criteria below.

Location: Hoag Memorial Hospital Presbyterian โ€” Newport Beach, 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 (13 Sites)

  • Hoag Memorial Hospital Presbyterian โ€” Newport Beach, California
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • Tennessee Oncology โ€” Nashville, Tennessee
  • START Dallas - Fort Worth โ€” Fort Worth, Texas
  • Concord Repatriation General Hospital Medical Oncology Clinical Trials Unit โ€” Concord, New South Wales
  • Macquarie University โ€” Sydney, New South Wales
  • Westmead Hospital โ€” Westmead, New South Wales
  • Peninsula & South Eastern Haematology and Oncology Group (PSEHOG) โ€” Frankston, Victoria
  • Alfred Health โ€” Melbourne, Victoria
  • Linear Clinical Research โ€” Nedlands, Western Australia
  • Auckland City Hospital โ€” Auckland,
  • National Cancer Centre Singapore โ€” Singapore,
  • Tan Tock Seng Hospital โ€” Singapore,

๐Ÿ“ž Contact the Study Coordinator

Phone: (615) 975-7776

Email: david.browning@iksuda.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.

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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†—