A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
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
1 other identifier
interventional
132
2 countries
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Jun 2023
Typical duration for phase_1 cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2023
CompletedFirst Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
March 20, 2026
March 1, 2026
3.9 years
June 22, 2023
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Pharmacokinetics (PK)
through study completion, an average of 1 year
Expression of anti-drug antibody (ADA)
through study completion, an average of 1 year
Efficacy assessment
through study completion, an average of 1 year
Other Outcomes (1)
Parts A and B, Exploratory: Correlatives
through study completion, an average of 1 year
Study Arms (2)
Part A, Dose Escalation
EXPERIMENTALParticipants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.
Part B, Dose Expansion
EXPERIMENTALParticipants receive CPO301 at the recommended phase 2 dose (RP2D) determined in Part A, administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.
Interventions
Administered by intravenous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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 Dallas
Dallas, Texas, 75039, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
July 17, 2023
Study Start
June 6, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share