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NCT Number: 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)

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.

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Key information

Conditions

Solid Tumor Cancer Biliary Tract Cancer (BTC) Biliary Tract Diseases Biliary Tract Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Digestive System Diseases Digestive System Neoplasms Epithelial Tumor Head and Neck Neoplasms Locally Advanced Lung Cancers Lung Diseases Lung Neoplasms Metastatic Solid Tumors Nasopharyngeal Cancers Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Stomatognathic Diseases Thoracic Neoplasms Urothelial Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Avenzo Therapeutics Recruiting Site, Gilbert, Arizona, United States

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About this study

This first-in-human, Phase 1/2 study will aim to obtain safety and tolerability data when AVZO-1418 is administered intravenously to patients with locally advanced or metastatic epithelial solid tumors.

Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-1418 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-1418 as a monotherapy. This data can guide selection of combination schedules and agents.

Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of AVZO-1418 as a monotherapy and potentially in combination therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVZO-1418

Drug

Specific dose in protocol specified schedule

Combination Agent 1

Drug

Per label based on combination agent used

Combination Agent 2

Drug

Per label based on combination agent used

Primary outcomes

  1. 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.

  2. Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)

    Time frame: Approximately 16 months

  3. 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)

  4. 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.

Secondary outcomes

  1. Objective Response Rate (ORR) (Phase 1)

    Time frame: From baseline through disease progression or study completion (approximately 2 years)

  2. Duration of Response (DOR) (Phase 1 and 2)

    Time frame: From baseline through disease progression or study completion (approximately 2 years)

    Defined as the time from the first confirmed response to radiologic/objective progression.

  3. Disease Control Rate (DCR) (Phase 1 and 2)

    Time frame: From baseline through disease progression or study completion (approximately 2 years)

    Defined as the proportion of patients who achieve tumor relief (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD.

  4. Progression Free Survival (PFS) (Phase 1 and 2)

    Time frame: From baseline through time to event on study or study completion (approximately 2 years)

    Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

  5. Overall Survival (OS) (Phase 1 and 2)

    Time frame: Approximately 76 months

    Defined as the time from study drug treatment initiation to death from any cause.

  6. PK Parameters: Maximum observed concentration (Cmax) (Phase 1)

    Time frame: Up to 2 years

  7. PK Parameters: Minimum observed concentration (Cmin) (Phase 1)

    Time frame: Up to 2 years

  8. PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)

    Time frame: Up to 2 years

  9. PK Parameters: Elimination half-life (T1/2) (Phase 1)

    Time frame: Up to 2 years

  10. PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)

    Time frame: Up to 2 years

  11. PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)

    Time frame: Up to 2 years

  12. PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)

    Time frame: Up to 2 years

  13. PK Parameters: Apparent Clearance (CL/F) (Phase 1)

    Time frame: Up to 2 years

  14. PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)

    Time frame: Up to 2 years

  15. PK Parameters: Accumulation ratio (AR) (Phase 1)

    Time frame: Up to 2 years

  16. Determination of RP2D (Phase 2)

    Time frame: Approximately 16 months

  17. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)

    Time frame: From baseline until end of study treatment or study completion (approximately 2 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

(858) 239-2944

Sponsors and collaborators

Lead sponsor

Avenzo Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 26, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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