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New treatment option for Cancer
Official title A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05948865
What this study is testing
What is CPO301?
CPO301 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Also referred to as SYS6010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Major
- Age ≥18 years
- Patients with histologically confirmed locally advanced or metastatic solid tumors who have disease progression, intolerance to prior therapy, are...
- In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type...
- In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR mutations based on previous biopsy result and Cohort 2 will be...
You likely can't join 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...
- 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...
- Had major surgery within 4 weeks before the first dose of the investigational drug in the study.
See the full eligibility criteria
- Major
- 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 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...
- 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...
- 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
- 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...
- 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...
- Had major surgery within 4 weeks before the first dose of the investigational drug in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newport Beach, California, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- Celebration, Florida, United States
- Sarasota, Florida, United States
- Lebanon, New Hampshire, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newport Beach, California, United States; Santa Monica, California, United States; Denver, Colorado, United States; Celebration, Florida, United States; Sarasota, Florida, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.