A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1
Conditions studied: Cancer, Cancer, Lung
In brief
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
Key facts
- Study ID
- NCT05948865
- Run by
- Conjupro Biotherapeutics, Inc.
- People needed
- 132
- Starts
- 2023-06-06
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States (enrolling)
- Sarah Cannon Research Institute (SCRI) at HealthONE — Denver, Colorado, United States (enrolling)
- AdventHealth Cancer Institute — Celebration, Florida, United States (enrolling)
- Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- NEXT Dallas — Dallas, Texas, United States (enrolling)
- NEXT Virginia — Fairfax, Virginia, United States (enrolling)
- Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
- Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
- Princess Margaret Cancer Centre - University Health Network — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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