Cancer Clinical Trial
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
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
Status | Recruiting |
Enrollment | 102 |
Est. completion date | December 12, 2025 |
Est. primary completion date | June 13, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Juravinski Cancer Centre | Hamilton | Ontario |
United States | AdventHealth Cancer Institute | Celebration | Florida |
United States | Sarah Cannon Research Institute (SCRI) at HealthONE | Denver | Colorado |
United States | NEXT Virginia | Fairfax | Virginia |
United States | USC Norris Comprehensive Cancer Center | Los Angeles | California |
United States | SCRI Oncology Partners | Nashville | Tennessee |
United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | UCLA Hematology/Oncology - Santa Monica | Santa Monica | California |
United States | Florida Cancer Specialists | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Conjupro Biotherapeutics, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parts A and B, Exploratory: Correlatives | To explore the correlation between EGFR status (different mutations, or amplification levels) and efficacy in patients with advanced solid tumors and biomarkers relevant to CPO301 efficacy | through study completion, an average of 1 year | |
Primary | To determine the dose to be used in Part B (RP2D) | To determine the recommended dose of CPO301 to be used as monotherapy in Part B (RP2D) | through study completion, an average of 1 year | |
Primary | Safety and tolerability at RP2D of CPO301 as monotherapy | as measured by Incidence and severity of AEs per CTCAEv5.0 | through study completion, an average of 1 year | |
Secondary | Pharmacokinetics (PK) | The pharmacokinetics (PK) profile of CPO301 will be assessed by measuring the blood concentration of the drug in the plasma at various timepoints and calculation of parameters, such as Peak Plasma Concentration (Cmax) | through study completion, an average of 1 year | |
Secondary | Expression of anti-drug antibody (ADA) | The expression of anti-drug antibodies (ADAs) following administration will be assessed by analysis of serum samples. | through study completion, an average of 1 year | |
Secondary | Efficacy assessment | To document any early indication of clinical efficacy | through study completion, an average of 1 year |
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