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RECRUITING
NCT05948865
PHASE1

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

Sponsor: Conjupro Biotherapeutics, Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2023-06-06

Completion Date

2027-08

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

CPO301

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