๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-29

A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (NCT05585320)

A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Immuneering Corporation

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

This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 candidate optimal dose of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in multiple Phase 2a proof-of-concept cohorts in malignancies of interest.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic โ€” Scottsdale, 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 (20 Sites)

  • Mayo Clinic โ€” Scottsdale, Arizona
  • City of Hope โ€” Duarte, California
  • University of California San Diego โ€” San Diego, California
  • Sarcoma Oncology Center โ€” Santa Monica, California
  • Sarah Cannon Research Institute โ€” Denver, Colorado
  • Mayo Clinic โ€” Jacksonville, Florida
  • Florida Cancer Specialists and Research Institute โ€” Lake Mary, Florida
  • Northwestern University โ€” Chicago, Illinois
  • University of Chicago โ€” Chicago, Illinois
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • Mayo Clinic โ€” Rochester, Minnesota
  • Hematology Oncology Associates of Central New York โ€” East Syracuse, New York
  • Weill Cornell Medicine โ€” New York, New York
  • Levine Cancer Center โ€” Charlotte, North Carolina
  • Duke University Cancer Institute โ€” Durham, North Carolina
  • SCRI Oncology Partners โ€” Nashville, Tennessee
  • MD Anderson Cancer Center โ€” Houston, Texas
  • NEXT Oncology โ€” San Antonio, Texas
  • NEXT Oncology โ€” Fairfax, Virginia
  • University of Wisconsin Clinical Science Center โ€” Madison, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

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†—