๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-27

IKS04 Regimen in Advanced Solid Tumors That Express CA242 (NCT07738939)

A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242

๐ŸŸก Not Yet Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Iksuda Therapeutics Ltd.

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

This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.

Who can join: Review the eligibility criteria below.

Location: UCLA Medical Center โ€” Los Angeles, California

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 (4 Sites)

  • UCLA Medical Center โ€” Los Angeles, California
  • Mass General Hospital โ€” Boston, Massachusetts
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • MD Anderson Cancer Center โ€” Houston, Texas

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.

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†—