Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official 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

Details

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.

Keywords

Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers, Epithelial Tumor, Biliary Tract Cancer (BTC), Urothelial Cancer, Nasopharyngeal Cancers, Solid Tumors, Metastatic, Lung Cancer, Epithelial Solid Tumors, Biliary Tract Cancer, SCLC, HER3, EGFR, BTC, Small Cell Lung Cancer, NSCLC, Lung Neoplasms, Carcinoma, Biliary Tract Neoplasms, Nasopharyngeal Neoplasms, Neoplasm Metastasis, Small Cell Lung Carcinoma, AVZO-1418, Combination Agent 1, Combination Agent 2

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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

  • Avenzo Therapeutics Recruiting Site accepting new patients
    Los Angeles California 90048 United States
  • Avenzo Therapeutics Recruiting Site accepting new patients
    Gilbert Arizona 85234 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avenzo Therapeutics, Inc.
Links
Sign up for this study
ID
NCT07038343
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 480 study participants
Last Updated