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AVENTINE-1 Study of AVZO-1418 for Advanced Solid Tumors

This study, called AVENTINE-1, is testing a new treatment called AVZO-1418. It will be given alone and possibly with other medicines to people with locally advanced or metastatic (spread to other parts of the body) solid tumors, including lung cancers and epithelial tumors. The main goals are to see how safe AVZO-1418 is, what side effects it causes, and to find the best dose. Researchers also want to see if it can shrink tumors. You might be able to join if you are between 18 and 75 years old, have a good general health status, and a life expectancy of more than 3 months. This study is currently unclear on its recruitment status and plans to enroll up to 480 participants.

Study design
This is a Phase 1/2 interventional study. It will first test AVZO-1418 alone to find a safe dose, then expand to assess its effectiveness alone and in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of treatment until the end of the study, which is approximately two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07038343

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)

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Avenzo Therapeutics, Inc.
~480 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:AVZO-1418Combination Agent 1Combination Agent 2

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Measured over Approximately 2 years
+3 more outcomes measured

Conditions

Solid Tumor Cancer
Locally Advanced
Metastatic Solid Tumors
Lung Cancers
Epithelial Tumor
Biliary Tract Cancer (BTC)
Urothelial Cancer
Nasopharyngeal Cancers

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Solid Neoplasm

NCT07038343

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Avenzo Therapeutics Recruiting Site

    Gilbert, Arizonano site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    Los Angeles, Californiano site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    Los Angeles, Californiano site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    Denver, Coloradono site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    New Haven, Connecticutno site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    Washington D.C., District of Columbiano site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    Orlando, Floridano site contact published

    Recruiting

  • Avenzo Therapeutics Recruiting Site

    Sarasota, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Medical Information
[email protected]
(858) 239-2944
Email the study team

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Eligibility criteria

Inclusion

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:
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.

Exclusion

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.

What this trial measures

  • Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)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)Approximately 16 months
  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)From baseline until end of study treatment or study completion (approximately 2 years)
  • Objective Response Rate (ORR) (Phase 2)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.