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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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.
More studies in Advanced Solid Tumor
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- A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors โ Glendale, California
- QTX3046 in Patients With KRAS G12D Mutations โ Grand Rapids, Michigan
- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors โ Houston, Texas
- First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer โ Fullerton, California
- A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors โ San Antonio, Texas
Explore by condition: All Advanced Solid Tumor clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.