A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT05948865. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05948865
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 5, 2023
- Primary completion
- Apr 30, 2027
- Completion
- Jul 31, 2027
- Last update posted
- Mar 19, 2026
2023 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | Recruiting |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | Recruiting |
| Sarah Cannon Research Institute (SCRI) at HealthONE | Denver | Colorado | 80218 | Recruiting |
| AdventHealth Cancer Institute | Celebration | Florida | 34747 | Recruiting |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| NEXT Dallas | Dallas | Texas | 75039 | Recruiting |
| NEXT Virginia | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05948865, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05948865 live on ClinicalTrials.gov.