Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05948865 | RECRUITING | Cancer

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

Conjupro Biotherapeutics, Inc.

Brief 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

Condition or disease

Cancer

Cancer, Lung

Intervention/treatment

CPO301

Phase

PHASE1

Detailed Description:

This Phase 1 study is a multicenter, dose-escalating, dose-expansion, single agent, 2-part study conducted in patients with advanced or metastatic solid tumors who progressed on ≥1 prior conventional systemic therapy or who were ineligible or intolerant to standard treatment or had no or refused standard treatment. Dose escalation (Part A) - Dose escalation will be guided by a modified 3+3 design to determine the maximum tolerated dose (MTD) or recommended dose of CPO301 (also known as SYS6010). Determination of dose-limiting toxicity (DLT) will be based on toxicity observed during the DLT observation period (first 21 days \[1 cycle\]). Dose escalation decisions are made based on the occurrence of DLT. MTD will be determined based on the data of all enrolled participants. To better identify the MTD, one or more dose groups may also be added beyond the planned maximum dose group (if determined to be safe), or between the maximum escalation dose group and the next lower dose group for DLT assessment. Intermediate dose groups and/or adjustment to the dosing frequency may be made Dose expansion (Part B) - Additional patients will be enrolled at the recommended dose determined in the dose escalation stage. An additional tumor cohort may be added based on data observed in Part A.

Study Type : INTERVENTIONAL
Estimated Enrollment : 102 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-06-06
Estimated Primary Completion Date : 2025-06-13
Estimated Study Completion Date : 2025-12-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Major Inclusion Criteria
  • * 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 Exclusion Criteria
    • * 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.
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors

Location Details

NCT05948865

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92658

RECRUITING

United States, California

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States, 90404

RECRUITING

United States, Colorado

Sarah Cannon Research Institute (SCRI) at HealthONE

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

AdventHealth Cancer Institute

Celebration, Florida, United States, 34747

RECRUITING

United States, Florida

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

RECRUITING

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

RECRUITING

United States, Pennsylvania

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

RECRUITING

United States, Tennessee

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Virginia

NEXT Virginia

Fairfax, Virginia, United States, 22031

RECRUITING

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

RECRUITING

Canada, Ontario

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

RECRUITING

Canada, Ontario

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada, M5G 2M9