Testing CPO301 in adults 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

This study is testing a new drug called CPO301 to see if it is safe and effective for adults with advanced or metastatic solid tumors, including Non-Small Cell Lung Cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Conjupro Biotherapeutics, Inc. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 14 sites (Los Angeles, California and 13 other locations)
• Trial ID: NCT05948865 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors who have progressed on prior therapies or are ineligible for standard treatments.

Not a fit: Patients with uncontrolled central nervous system metastases or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.

How similar studies have performed: While this approach is novel in its specific application, similar studies using antibody drug conjugates have shown promise in treating various cancers.

Eligibility 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.

Where this trial is running

Los Angeles, California and 13 other locations

• 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)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
• SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
• NEXT Dallas — Dallas, Texas, United States (RECRUITING)
• NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
• Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)
• Juravinski Cancer Centre — Hamilton, Ontario, Canada (RECRUITING)
• Princess Margaret Cancer Centre - University Health Network — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Kevin Romanko

Conditions: Cancer, Cancer, Lung, Non-Small Cell Lung Cancer, Solid Tumors, Metastatic, Advanced