Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

Sponsor: Avenzo Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07038343

This Phase 1/2 trial evaluates the safety, tolerability, and antitumor activity of AVZO-1418 in patients with advanced epithelial solid tumors. Phase 1 focuses on dose escalation to determine the MTD and RP2D, while Phase 2 explores efficacy as monotherapy and in combination. Interventions include AVZO-1418 and potential combination agents per protocol.

Patient Parameters

Program Overview

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.

Description

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.

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.

Locations

FACILITYZIPCITYSTATE
Avenzo Therapeutics Recruiting Site80218DenverColorado
Avenzo Therapeutics Recruiting Site32827OrlandoFlorida
Avenzo Therapeutics Recruiting Site34232SarasotaFlorida
Avenzo Therapeutics Recruiting Site75039DallasTexas
Avenzo Therapeutics Recruiting Site77054HoustonTexas
Avenzo Therapeutics Recruiting Site78229San AntonioTexas
Avenzo Therapeutics Recruiting Site84119West Valley CityUtah
Avenzo Therapeutics Recruiting Site22031FairfaxVirginia

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