Testing CPO301 in adults with advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety and tolerability of CPO301, an antibody drug conjugate, in adult patients with advanced or metastatic solid tumors. The study is divided into two parts: Part A focuses on dose escalation to determine the maximum tolerated dose, while Part B assesses the safety and efficacy of the recommended dose in patients with Non-Small Cell Lung Cancer and other tumor types. Participants will undergo screening tests, receive the study drug, and attend required visits to monitor their health and response to treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• UCLA Hematology/Oncology - Santa Monica
  Santa Monica, California, United States Recruiting
• Sarah Cannon Research Institute (SCRI) at HealthONE
  Denver, Colorado, United States Recruiting
• AdventHealth Cancer Institute
  Celebration, Florida, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting

Study contacts

• Study coordinator: Kevin Romanko
• Email: clinicaltrials.gov@cspcus.com
• Phone: 609-686-6502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.