A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 20, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Conjupro Biotherapeutics, Inc.
- Interventions being studied
- Drug: CPO301
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Major
- Age ≥18 years
- Patients with histologically confirmed locally advanced or metastatic solid tumors who have disease progression, intolerance to prior therapy, are ineligible for available therapies, or refuse standard of care therapy in the metastatic setting.
- In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head \& neck cancer based on previous biopsy result.
- In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR mutations based on previous biopsy result and Cohort 2 will be patients with other cancer(s) suggested to have sensitivity to CPO301 in Part A.
- At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1
- ECOG performance status 0 or 1 at screening
- Life expectancy \>12 weeks Major
- Known, active, or uncontrolled central nervous system (CNS) metastasis or carcinomatous meningitis.
- Has AEs due to previous anti-tumor treatments not recovered to ≤Grade 1 (except for alopecia; some tolerable chronic toxicities of Grade 2 may be excluded after consultation with the sponsor, as judged by the investigator) according to NCI-CTCAE v5.0.
- Any serious and/or uncontrolled concurrent illness that may interfere with study participation Prior therapy
- Received other investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study
- The time interval between the latest anti-tumor treatment and the first dose of the investigational drug meets the following requirements: 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; have received oral fluoropyrimidines, small molecule targeted drugs within 2 weeks before the first dose of the investigational drug; have received palliative radiotherapy or local therapy within 2 weeks before the first dose of investigational drug.
- Had major surgery within 4 weeks before the first dose of the investigational drug in the study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California
- Sarah Cannon Research Institute (SCRI) at HealthONEDenver, Colorado
- AdventHealth Cancer InstituteCelebration, Florida
- Florida Cancer SpecialistsSarasota, Florida
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- SCRI Oncology PartnersNashville, Tennessee
- NEXT DallasDallas, Texas
- NEXT VirginiaFairfax, Virginia
- Cross Cancer InstituteEdmonton, Alberta
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 20, 2026. Always confirm current availability with the study team.