OncoMatch/Clinical Trials/NCT05948865
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Is NCT05948865 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies CPO301 for cancer.
Treatment: CPO301 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Biomarker criteria
Required: EGFR mutation
Required: KRAS wild-type
Disease stage
Metastatic disease required
Patients with histologically confirmed locally advanced or metastatic solid tumors...At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational drug
Received other investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study
Cannot have received: chemotherapy
Exception: within 4 weeks before the first dose
Have received anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and other clinical investigational drugs within 4 weeks before the first dose of the investigational drug
Cannot have received: oral fluoropyrimidines
Exception: within 2 weeks before the first dose
have received oral fluoropyrimidines, small molecule targeted drugs within 2 weeks before the first dose of the investigational drug
Cannot have received: small molecule targeted drug
Exception: within 2 weeks before the first dose
have received oral fluoropyrimidines, small molecule targeted drugs within 2 weeks before the first dose of the investigational drug
Cannot have received: palliative radiotherapy or local therapy
Exception: within 2 weeks before the first dose
have received palliative radiotherapy or local therapy within 2 weeks before the first dose of investigational drug
Cannot have received: major surgery
Exception: within 4 weeks before the first dose
Had major surgery within 4 weeks before the first dose of the investigational drug in the study
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05948865 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, chemotherapy, oral fluoropyrimidines disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify