AVZO-103 alone and with other treatments for advanced urothelial and other 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 program gives AVZO-103 intravenously as monotherapy and in combination to adults with locally advanced or metastatic urothelial carcinoma and selected other solid tumors. Phase 1 uses dose escalation to characterize safety, tolerability, pharmacokinetics/pharmacodynamics, and to determine the maximum tolerated dose and a preliminary recommended Phase 2 dose. Phase 2 expands selected dose cohorts to measure antitumor activity using RECIST v1.1 and further define safety and PK. Participants must have measurable disease, ECOG performance status ≤1, provide molecular test results and tumor tissue, and are excluded if they have active untreated CNS metastases.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Patient must be an adult, 18 years of age and older 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 urothelial cancer and other 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:

* 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.
* Prior Stevens-Johnson syndrome/toxic epidermal necrolysis.
* 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 allogenic stem cell or solid organ transplant.
* Other protocol-defined Exclusion criteria apply.

Where it's running

• Avenzo Therapeutics Recruiting Site
  San Francisco, California, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Aurora, Colorado, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  New Haven, Connecticut, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Orlando, Florida, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Tampa, Florida, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Boston, Massachusetts, 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.