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 study on Solid Tumor Locally Advanced Lung Cancer Epithelial Tumor Biliary Tract Cancer Transitional Cell Carcinoma Nasopharyngeal Cancer Lung Tumor Carcinoma
Summary
- Eligibility
- for people ages 18-75 (full criteria)
- Location
- at UCLA
- Dates
- study startedstudy ends around
Description
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.
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
Details
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.
Keywords
Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers, Epithelial Tumor, Biliary Tract Cancer (BTC), Urothelial Cancer, Nasopharyngeal Cancers, Solid Tumors, Metastatic, Lung Cancer, Epithelial Solid Tumors, Biliary Tract Cancer, SCLC, HER3, EGFR, BTC, Small Cell Lung Cancer, NSCLC, Lung Neoplasms, Carcinoma, Biliary Tract Neoplasms, Nasopharyngeal Neoplasms, Neoplasm Metastasis, Small Cell Lung Carcinoma, AVZO-1418, Combination Agent 1, Combination Agent 2
Eligibility
You can join if…
Open to people ages 18-75
- 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.
You CAN'T join if...
- 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.
Locations
- Avenzo Therapeutics Recruiting Site
accepting new patients
Los Angeles California 90095 United States - Avenzo Therapeutics Recruiting Site
accepting new patients
Los Angeles California 90048 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Avenzo Therapeutics, Inc.
- ID
- NCT07038343
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 480 study participants
- Last Updated
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