NCT07038343 · Avenzo Therapeutics, Inc.
Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
What this study is about
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, how the drug moves through the body, how the drug affects the body, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered given through a vein (IV) as a treatment given alone and potentially in two or more treatments used together to patients with locally advanced or metastatic epithelial solid tumors.
View original scientific description
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.
Interventions
DRUG
AVZO-1418
Specific dose in protocol specified schedule
DRUG
Combination Agent 1
Per label based on combination agent used
DRUG
Combination Agent 2
Per label based on combination agent used
Primary outcome measures
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Time frame: Approximately 2 years
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)
Time frame: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 requi
Where
- Gilbert, Arizona
- Los Angeles, California
- Denver, Colorado
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Orlando, Florida
- Sarasota, Florida
- Tampa, Florida
- Atlanta, Georgia
- Boston, Massachusetts
- New York, New York
- Philadelphia, Pennsylvania
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations