RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-06-06
Study Completion:2025-12-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05948865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * 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.
  3. * 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.
  4. * 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.
  5. * At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1
  6. * ECOG performance status 0 or 1 at screening
  7. * Life expectancy \>12 weeks
  1. * Known, active, or uncontrolled central nervous system (CNS) metastasis or carcinomatous meningitis.
  2. * 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.
  3. * Any serious and/or uncontrolled concurrent illness that may interfere with study participation
  4. * Received other investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study
  5. * 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.
  6. * Had major surgery within 4 weeks before the first dose of the investigational drug in the study.

Contacts and Locations

Study Contact

Kevin Romanko
CONTACT
609-686-6502
clinicaltrials.gov@cspcus.com
Audrey Li
CONTACT
609-356-0210
clinicaltrials.gov@cspcus.com

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
United States
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, 80218
United States
AdventHealth Cancer Institute
Celebration, Florida, 34747
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Conjupro Biotherapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06
Study Completion Date2025-12-12

Study Record Updates

Study Start Date2023-06-06
Study Completion Date2025-12-12

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Non-Small Cell Lung Cancer
  • Solid Tumors
  • Metastatic
  • Advanced

Additional Relevant MeSH Terms

  • Cancer
  • Cancer, Lung