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A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Sponsor: Conjupro Biotherapeutics, Inc.
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2023-06-06
Completion Date
2027-08
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
CPO301
Administered by intravenous injection
Locations (14)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, United States
AdventHealth Cancer Institute
Celebration, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Dallas
Dallas, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada