Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer (BTC) | Malignant Biliary Tract Neoplasm | ALIAS | 0.85 |
| Epithelial Tumor | — | UNRESOLVED | — |
| Locally Advanced | — | UNRESOLVED | — |
| Lung Cancers | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Nasopharyngeal Cancers | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor Cancer | — | UNRESOLVED | — |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVZO-1418 | Drug | — | UNRESOLVED |
| Combination Agent 1 | Drug | — | UNRESOLVED |
| Combination Agent 2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1, monotherapy
- description
- Group A
- interventionNames
- Drug: AVZO-1418
- type
- EXPERIMENTAL
- label
- Phase 1, combination
- description
- Group B
- interventionNames
- Drug: AVZO-1418
- Drug: Combination Agent 1
- Drug: Combination Agent 2
- type
- EXPERIMENTAL
- label
- Phase 2, monotherapy
- description
- Part A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available