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AVZO-1418 alone and with other treatments for advanced epithelial solid tumors

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

Phase1; Phase2 Interventional Avenzo Therapeutics, Inc. · NCT07038343

This trial will test whether intravenous AVZO-1418, alone or with other cancer drugs, is safe and helps adults with locally advanced or metastatic epithelial solid tumors, including some lung cancers.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAvenzo Therapeutics, Inc. Industry-sponsored
Locations18 sites (Gilbert, Arizona and 17 other locations)
Trial IDNCT07038343 on ClinicalTrials.gov

What this trial studies

This first-in-human phase 1/2 trial gives AVZO-1418 intravenously to adults with locally advanced or metastatic epithelial solid tumors to determine safety, dosing, and preliminary anti-tumor activity. Phase 1 uses dose escalation to find the maximum tolerated dose and recommended Phase 2 dose; Phase 2 expands selected cohorts to measure tumor responses as monotherapy and possibly in defined combinations. Patients must have measurable disease per RECIST v1.1, provide molecular testing results and tumor tissue, and meet performance-status and other inclusion criteria. Key exclusions include uncontrolled hypertension and active CNS metastases unless treated and radiologically stable.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed locally advanced or metastatic epithelial solid tumors, ECOG ≤1, measurable disease, life expectancy >3 months, and willingness to provide molecular test results and tumor tissue are the intended participants.

Not a fit: Patients with uncontrolled hypertension, active untreated CNS metastases, or who do not meet molecular testing or performance-status requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AVZO-1418 could offer a new systemic treatment that shrinks tumors or controls disease in patients with advanced epithelial solid tumors.

How similar studies have performed: This is the first-in-human trial of AVZO-1418, so the agent itself is untested in people although other targeted systemic therapies for epithelial tumors have shown benefit in some settings.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gilbert, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumor CancerLocally AdvancedMetastatic Solid TumorsLung CancersEpithelial TumorBiliary Tract CancerUrothelial CancerNasopharyngeal Cancers
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.