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CancerGeneticsDrugPhase 1

What this study is

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

What's being tested

  • CPO301

    Intervention · DRUG

    Administered by intravenous injection

Study details

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
Sponsor
Conjupro Biotherapeutics, Inc.
Conditions
Cancer · Cancer, Lung
Enrolling
132 people
Starts
2023-06-06
Est. completion
2027-08
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗