A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors (NCT05948865)
A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO301, an EGFR-Targeting Antibody-Drug Conjugate, in Adult Patients With Advanced or Metastatic Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors. The main questions it aims to answer are: * To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A) * To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B) * To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK) * To evaluate if antibodies to the study drug develop (immunogenicity) * To evaluate preliminary efficacy to the drug * To correlate preliminary efficacy with mutations in a biomarker called EGFR Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment * Be followed for progression every 3 months for up to 2 years
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- UCLA Hematology/Oncology - Santa Monica — Santa Monica, California
- Sarah Cannon Research Institute (SCRI) at HealthONE — Denver, Colorado
- AdventHealth Cancer Institute — Celebration, Florida
- Florida Cancer Specialists — Sarasota, Florida
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- SCRI Oncology Partners — Nashville, Tennessee
- NEXT Dallas — Dallas, Texas
- NEXT Virginia — Fairfax, Virginia
- Cross Cancer Institute — Edmonton, Alberta
- Juravinski Cancer Centre — Hamilton, Ontario
- Princess Margaret Cancer Centre - University Health Network — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (609) 686-6502
Email: clinicaltrials.gov@cspcus.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.
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💡 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.