RecruitingPhase 1NCT05948865

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors

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


Sponsor

Conjupro Biotherapeutics, Inc.

Enrollment

132 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called CPO301 in people with advanced or metastatic solid tumors that have not responded to prior treatments. The study aims to find the right dose and understand how the drug behaves, with a focus on lung, breast, colorectal, and head and neck cancers, as well as lung cancers with EGFR mutations. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic solid tumor - Your cancer has progressed despite prior treatments, or you are not eligible for or have declined standard treatments - You have at least one measurable tumor on imaging - You are in good physical condition (ECOG 0–1) with a life expectancy of more than 12 weeks **You may NOT be eligible if...** - You have active, uncontrolled cancer in the brain or spinal fluid - You have not recovered from side effects of prior cancer treatments - You have a serious uncontrolled illness that would interfere with participation - You received other investigational drugs or treatments recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCPO301

Administered by intravenous injection


Locations(14)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Sarah Cannon Research Institute (SCRI) at HealthONE

Denver, Colorado, United States

AdventHealth Cancer Institute

Celebration, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

NEXT Dallas

Dallas, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05948865


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