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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1, monotherapy 		Group A
  • Drug: AVZO-1418
    Specific dose in protocol specified schedule
Experimental
Phase 1, combination 		Group B
  • Drug: AVZO-1418
    Specific dose in protocol specified schedule
  • Drug: Combination Agent 1
    Per label based on combination agent used
  • Drug: Combination Agent 2
    Per label based on combination agent used
Experimental
Phase 2, monotherapy 		Part A
  • Drug: AVZO-1418
    Specific dose in protocol specified schedule
Experimental
Phase 2, combination 		Part B
  • Drug: AVZO-1418
    Specific dose in protocol specified schedule
  • Drug: Combination Agent 1
    Per label based on combination agent used
  • Drug: Combination Agent 2
    Per label based on combination agent used

Recruiting Locations

Avenzo Therapeutics Recruiting Site
Denver 5419384, Colorado 5417618 80218
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
Orlando 4167147, Florida 4155751 32827
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
Sarasota 4172131, Florida 4155751 34232
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
Dallas 4684888, Texas 4736286 75039
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
Houston 4699066, Texas 4736286 77054
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
San Antonio 4726206, Texas 4736286 78229
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
West Valley City 5784607, Utah 5549030 84119
Contact:
Avenzo Therapeutics

Avenzo Therapeutics Recruiting Site
Fairfax 4758023, Virginia 6254928 22031
Contact:
Avenzo Therapeutics

More Details

Status
Recruiting
Sponsor
Avenzo Therapeutics, Inc.

Study Contact

Medical Information
(858) 239-2944
ClinicalTrials@avenzotx.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.