NCT07038343RecruitingPhase 1/2
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)
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 4 Jun 2025
- Primary completion date
- Jun 2030
- Lead sponsor
- Avenzo Therapeutics, Inc.
- NCT number
- NCT07038343
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 480
- From 4 Jun 2025 to the primary completion date, Jun 2030
- 26 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.
Other illness
- Uncontrolled hypertension.
- History of drug-induced interstitial lung disease (ILD).
- History of any serious cardiovascular condition.
- History of a solid organ transplant.
Other
- Other protocol-defined Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.