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)
A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This first study of AVZO-1418 tests its safety, side effects, dose, and effects on cancer and the body. It is for adults with certain solid tumors that have grown into nearby areas or spread to other parts of the body. The drug is given through a vein, alone and possibly with other treatments.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 75 years old, able to do most daily activities, and expected to live more than 3 months.
- Have a type of epithelial solid tumor allowed by the study, confirmed by tissue or cell tests. These cancers start in cells that cover or line organs and must have grown nearby or spread.
- Have cancer that the study doctor can measure using standard rules.
- Agree to share molecular test results to check eligibility and provide stored tumor tissue and/or a new tumor sample, as needed.
- Meet other study rules for joining.
Who can't join
- High blood pressure that is not controlled.
- Active cancer spread to the brain or spinal cord. Treated brain spread may be allowed if it causes no symptoms, scans show no change for at least 4 weeks before the first dose, and steroids are not needed.
- Known or suspected cancer spread to the lining around the brain or spinal cord, even if treated.
- A history of drug-caused lung inflammation or scarring.
- A history of any serious heart or blood vessel condition.
- An infection needing antibiotics, antiviral drugs, or antifungal drugs through a vein within 2 weeks before the first dose.
- A past solid organ transplant.
- Other study rules may prevent you from joining.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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.
Study sites (19)
AZ
- Avenzo Therapeutics Recruiting Site · Gilbert, AZ 85234Avenzo Therapeutics · Study contactMore trials in Gilbert
CA
- Avenzo Therapeutics Recruiting Site · Los Angeles, CA 90048Avenzo Therapeutics · Study contact · GroupCancerTrialINformation@cshs.orgMore trials in Los Angeles
- Avenzo Therapeutics Recruiting Site · Los Angeles, CA 90095Avenzo Therapeutics · Study contactMore trials in Los Angeles
CO
- Avenzo Therapeutics Recruiting Site · Denver, CO 80218Avenzo Therapeutics · Study contactMore trials in Denver
CT
- Avenzo Therapeutics Recruiting Site · New Haven, CT 06510Avenzo Therapeutics · Study contactMore trials in New Haven
DC
- Avenzo Therapeutics Recruiting Site · Washington D.C., DC 20007Avenzo Therapeutics · Study contactMore trials in Washington D.C.
FL
- Avenzo Therapeutics Recruiting Site · Orlando, FL 32827Avenzo Therapeutics · Study contactMore trials in Orlando
- Avenzo Therapeutics Recruiting Site · Sarasota, FL 34232Avenzo Therapeutics · Study contactMore trials in Sarasota
- Avenzo Therapeutics Recruiting Site · Tampa, FL 33612Avenzo Therapeutics · Study contactMore trials in Tampa
GA
- Avenzo Therapeutics Recruiting Site · Atlanta, GA 30322Avenzo Therapeutics · Study contactMore trials in Atlanta
MA
- Avenzo Therapeutics Recruiting Site · Boston, MA 02215Avenzo Therapeutics · Study contactMore trials in Boston
NY
- Avenzo Therapeutics Recruiting Site · New York, NY 10029Avenzo Therapeutics · Study contactMore trials in New York
PA
- Avenzo Therapeutics Recruiting Site · Philadelphia, PA 19107Avenzo Therapeutics · Study contactMore trials in Philadelphia
TX
- Avenzo Therapeutics Recruiting Site · Dallas, TX 75039Avenzo Therapeutics · Study contactMore trials in Dallas
- Avenzo Therapeutics Recruiting Site · Houston, TX 77054Avenzo Therapeutics · Study contactMore trials in Houston
- Avenzo Therapeutics Recruiting Site · San Antonio, TX 78229Avenzo Therapeutics · Study contactMore trials in San Antonio
UT
- Avenzo Therapeutics Recruiting Site · West Valley City, UT 84119Avenzo Therapeutics · Study contactMore trials in West Valley City
VA
- Avenzo Therapeutics Recruiting Site · Fairfax, VA 22031Avenzo Therapeutics · Study contactMore trials in Fairfax
WA
- Avenzo Therapeutics Recruiting Site · Seattle, WA 98109Avenzo Therapeutics · Study contactMore trials in Seattle