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
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
480
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Lead sponsor
Avenzo Therapeutics, Inc.
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Start date
2025-06-04
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Number of sites
19
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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.
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Short title
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)
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2030-12-01
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First posted
2025-06-26
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Registry last updated
2026-08-28
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Primary completion date
2030-06-01
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Start date
2025-06-04
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Participants
480
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Participant count basis
Estimated
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Planned participants
480
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Protocol amendments
2
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Number of sites
19
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Avenzo Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07038343
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ClinicalTrials.gov ID
NCT07038343
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)

    Timeframe: Approximately 2 years

    Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.

  2. Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)

    Timeframe: Approximately 16 months

  3. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)

    Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

  4. Objective Response Rate (ORR) (Phase 2)

    Timeframe: From baseline through disease progression or study completion (approximately 2 years)

    Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

  1. Objective Response Rate (ORR) (Phase 1)

    Timeframe: From baseline through disease progression or study completion (approximately 2 years)

  2. Duration of Response (DOR) (Phase 1 and 2)

    Timeframe: From baseline through disease progression or study completion (approximately 2 years)

    Defined as the time from the first confirmed response to radiologic/objective progression.

  3. Disease Control Rate (DCR) (Phase 1 and 2)

    Timeframe: From baseline through disease progression or study completion (approximately 2 years)

    Defined as the proportion of patients who achieve tumor relief (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD.

  4. Progression Free Survival (PFS) (Phase 1 and 2)

    Timeframe: From baseline through time to event on study or study completion (approximately 2 years)

    Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

  5. Overall Survival (OS) (Phase 1 and 2)

    Timeframe: Approximately 76 months

    Defined as the time from study drug treatment initiation to death from any cause.

  6. PK Parameters: Maximum observed concentration (Cmax) (Phase 1)

    Timeframe: Up to 2 years

  7. PK Parameters: Minimum observed concentration (Cmin) (Phase 1)

    Timeframe: Up to 2 years

  8. PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)

    Timeframe: Up to 2 years

  9. PK Parameters: Elimination half-life (T1/2) (Phase 1)

    Timeframe: Up to 2 years

  10. PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)

    Timeframe: Up to 2 years

  11. PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)

    Timeframe: Up to 2 years

  12. PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)

    Timeframe: Up to 2 years

  13. PK Parameters: Apparent Clearance (CL/F) (Phase 1)

    Timeframe: Up to 2 years

  14. PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)

    Timeframe: Up to 2 years

  15. PK Parameters: Accumulation ratio (AR) (Phase 1)

    Timeframe: Up to 2 years

  16. Determination of RP2D (Phase 2)

    Timeframe: Approximately 16 months

  17. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)

    Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

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.
Sources for eligibility
clinicaltrials.gov

  • Avenzo Therapeutics Recruiting SiteGilbert, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteLos Angeles, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteSanta Monica, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteDenver, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteNew Haven, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteWashington D.C., United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteOrlando, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteSarasota, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteTampa, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteAtlanta, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteBoston, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteNew York, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SitePhiladelphia, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteDallas, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteHouston, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteSan Antonio, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteWest Valley City, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteFairfax, United StatesRecruiting
  • Avenzo Therapeutics Recruiting SiteSeattle, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (9)