🏛️ Verified NIH Record • Updated 2026-08-13

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (NCT04929223)

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (18 items).

Location: UAB Comprehensive Cancer Center — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria
  • Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.
  • Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled tumor-related pain
  • Uncontrolled or symptomatic hypercalcemia
  • Clinically significant and active liver disease

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (84 Sites)

Showing the first 25 of 84 sites.

  • UAB Comprehensive Cancer Center — Birmingham, Alabama
  • Mayo Clinic Arizona — Phoenix, Arizona
  • City of Hope Comprehensive Cancer Center — Duarte, California
  • cCare — Encinitas, California
  • USC Norris Cancer Center — Los Angeles, California
  • Cedars-Sinai Medical Center — Los Angeles, California
  • UCLA — Los Angeles, California
  • Hoag Memorial Hospital Presbyterian — Newport Beach, California
  • Stanford Cancer Center — Stanford, California
  • University of Colorado Cancer Center — Aurora, Colorado
  • Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado
  • Yale Cancer Center — New Haven, Connecticut
  • Eastern Ct Hema/Onco Assoc — Norwich, Connecticut
  • Mayo Clinic in Florida — Jacksonville, Florida
  • Moffitt Cancer Center — Tampa, Florida
  • Illinois Cancer Specialists — Arlington Heights, Illinois
  • Mary Bird Perkins Cancer Ctr — Baton Rouge, Louisiana
  • Massachusetts General Hospital — Boston, Massachusetts
  • Karmanos Cancer Institute — Detroit, Michigan
  • Mayo Clinic Rochester — Rochester, Minnesota
  • New York Cancer & Blood Specialists - New Hyde Park — New Hyde Park, New York
  • New York Cancer and Blood Specialists-Central Park Hematology & Oncology — New York, New York
  • New York Cancer & Blood Specialists — Port Jefferson Station, New York
  • New York Cancer & Blood Specialists - Bronx — The Bronx, New York
  • Duke University Medical Center — Durham, North Carolina

📞 Contact the Study Coordinator

Phone: (888) 662-6728

Email: global-roche-genentech-trials@gene.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 § 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 Metastatic Colorectal Cancer

Explore by condition: All Metastatic Colorectal Cancer clinical trials

💡 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.
🏛️ View Official NIH Record ↗