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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)
NCT07038343 · Avenzo Therapeutics, Inc.
In plain English
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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
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.
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.
Study design
Enrollment target: 480 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-04
Estimated completion: 2030-12
Last updated: 2026-05-13
Interventions
Drug: AVZO-1418Drug: Combination Agent 1Drug: Combination Agent 2
Primary outcomes
- • Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) (Approximately 2 years)
- • Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1) (Approximately 16 months)
- • Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) (From baseline until end of study treatment or study completion (approximately 2 years))
Sponsor
Avenzo Therapeutics, Inc. · industry
Contacts & investigators
ContactMedical Information · contact · ClinicalTrials@avenzotx.com · (858) 239-2944
All locations (18)
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Gilbert, Arizona, United States
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Los Angeles, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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West Valley City, Utah, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States