AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
480 (estimated)
Sponsor
Avenzo Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with specific types of advanced solid tumors. Participants will receive a treatment called AVZO-1418 to see how safe it is and whether it helps fight their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 to 75 years
I have a life expectancy of more than 3 months
I have been diagnosed with advanced or metastatic solid tumors
I have measurable disease
I agree to provide my tumor test results
I can submit tumor samples or biopsies if needed
You may not be able to join if
I have uncontrolled high blood pressure
I have active brain metastases
I have a history of lung disease caused by drugs
I have a serious heart condition
I have had an infection that required IV treatment in the past 2 weeks
I have received an organ transplant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.
Trial Locations
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Eligibility Criteria
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 …
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.
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