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 (May 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
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 →
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