AVZO-1418 alone and with other treatments for advanced epithelial 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 first-in-human phase 1/2 trial gives AVZO-1418 intravenously to adults with locally advanced or metastatic epithelial solid tumors to determine safety, dosing, and preliminary anti-tumor activity. Phase 1 uses dose escalation to find the maximum tolerated dose and recommended Phase 2 dose; Phase 2 expands selected cohorts to measure tumor responses as monotherapy and possibly in defined combinations. Patients must have measurable disease per RECIST v1.1, provide molecular testing results and tumor tissue, and meet performance-status and other inclusion criteria. Key exclusions include uncontrolled hypertension and active CNS metastases unless treated and radiologically stable.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

* Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months.
* Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:

  o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).
* Measurable disease as assessed by Investigator using RECIST v1.1.
* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.
* Other protocol-defined Inclusion criteria apply.

Key Exclusion Criteria

* Uncontrolled hypertension.
* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.
* History of drug-induced interstitial lung disease (ILD).
* History of any serious cardiovascular condition.
* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.
* History of a solid organ transplant.
* Other protocol-defined Exclusion criteria apply.

Where it's running

• Avenzo Therapeutics Recruiting Site
  Gilbert, Arizona, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Los Angeles, California, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Los Angeles, California, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Denver, Colorado, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  New Haven, Connecticut, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Medical Information
• Email: ClinicalTrials@avenzotx.com
• Phone: (858) 239-2944

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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.