Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
NCT ID: NCT07038343
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
430 participants
INTERVENTIONAL
2025-06-04
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1, monotherapy
Group A
AVZO-1418
Specific dose in protocol specified schedule
Phase 1, combination
Group B
AVZO-1418
Specific dose in protocol specified schedule
Combination Agent 1
Per label based on combination agent used
Combination Agent 2
Per label based on combination agent used
Phase 2, monotherapy
Part A
AVZO-1418
Specific dose in protocol specified schedule
Phase 2, combination
Part B
AVZO-1418
Specific dose in protocol specified schedule
Combination Agent 1
Per label based on combination agent used
Combination Agent 2
Per label based on combination agent used
Interventions
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AVZO-1418
Specific dose in protocol specified schedule
Combination Agent 1
Per label based on combination agent used
Combination Agent 2
Per label based on combination agent used
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Avenzo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Avenzo Therapeutics Recruiting Site
Gilbert, Arizona, United States
Avenzo Therapeutics Recruiting Site
Denver, Colorado, United States
Avenzo Therapeutics Recruiting Site
Washington D.C., District of Columbia, United States
Avenzo Therapeutics Recruiting Site
Orlando, Florida, United States
Avenzo Therapeutics Recruiting Site
Sarasota, Florida, United States
Avenzo Therapeutics Recruiting Site
Philadelphia, Pennsylvania, United States
Avenzo Therapeutics Recruiting Site
Dallas, Texas, United States
Avenzo Therapeutics Recruiting Site
Houston, Texas, United States
Avenzo Therapeutics Recruiting Site
San Antonio, Texas, United States
Avenzo Therapeutics Recruiting Site
West Valley City, Utah, United States
Avenzo Therapeutics Recruiting Site
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Avenzo Therapeutics
Role: primary
Other Identifiers
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AVZO-1418-1001
Identifier Type: -
Identifier Source: org_study_id
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