A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Condition(s) studied
Study 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
Eligibility
Primary outcome measure(s)
- To determine the dose to be used in Part B (RP2D) — through study completion, an average of 1 year
To determine the recommended dose of CPO301 to be used as monotherapy in Part B (RP2D) - Safety and tolerability at RP2D of CPO301 as monotherapy — through study completion, an average of 1 year
as measured by Incidence and severity of AEs per CTCAEv5.0
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | Recruiting |
| Sarah Cannon Research Institute (SCRI) at HealthONE | Denver | Colorado | Recruiting |
| AdventHealth Cancer Institute | Celebration | Florida | Recruiting |
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| NEXT Dallas | Dallas | Texas | Recruiting |
| NEXT Virginia | Fairfax | Virginia | Recruiting |
| Cross Cancer Institute | Edmonton | Alberta | Recruiting |
| Juravinski Cancer Centre | Hamilton | Ontario | Recruiting |
| Princess Margaret Cancer Centre - University Health Network | Toronto | Ontario | Recruiting |
More Conjupro Biotherapeutics, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05948865 on ClinicalTrials.gov ↗ ← All trials in the USA