๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-18

A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations (NCT05163028)

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: HUYABIO International, LLC.

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

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.

Who can join: Review the eligibility criteria below.

Location: City of Hope โ€” Duarte, 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 (12 Sites)

  • City of Hope โ€” Duarte, California
  • California Cancer Associates for Research and Excellence, Inc. (cCare) โ€” Encinitas, California
  • Providence Medical Foundation โ€” Fullerton, California
  • California Cancer Associates for Research and Excellence, Inc. (cCare) โ€” San Marcos, California
  • Sarcoma Oncology โ€” Santa Monica, California
  • UCLA Hematology/Oncology โ€” Santa Monica, California
  • Orlando Health, Inc. โ€” Orlando, Florida
  • BRCR Medical Center โ€” Plantation, Florida
  • Gabrail Cancer Center โ€” Canton, Ohio
  • Texas Oncology - Tyler โ€” Tyler, Texas
  • Virginia Cancer Specialists โ€” Fairfax, Virginia
  • Pan American Center for Oncology Trials (PanOncology Trials) โ€” Rio Piedras, Puerto Rico

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 826-4673

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†—