Study on AVZO-1418 Alone and in Combination for Patients with Advanced Solid Tumors
Sponsor: Avenzo Therapeutics, Inc.
ClinicalTrials ID:NCT07038343
This clinical trial is testing a new drug, AVZO-1418, to see if it is safe and effective for treating patients with advanced solid tumors. The study will look at how the drug works on its own and possibly in combination with other treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called AVZO-1418 in patients with advanced solid tumors. Researchers want to find out how well the drug is tolerated, how it behaves in the body, and its potential to reduce tumors. The study will test AVZO-1418 both as a single treatment and possibly in combination with other therapies.
Description
This study is the first time AVZO-1418 is being tested in humans. It is divided into two phases:
-
Phase 1: This part of the study will focus on finding the safest dose of AVZO-1418 that patients can tolerate. Researchers will gradually increase the dose to determine the maximum amount that can be given safely. This phase will help decide the best dose to use in future studies and how it might be combined with other treatments.
-
Phase 2: In this phase, researchers will look at how well AVZO-1418 works in shrinking tumors. They will test the drug on its own and may also explore how it works when combined with other treatments. The goal is to see if AVZO-1418 can effectively treat advanced solid tumors.
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Avenzo Therapeutics Recruiting Site | 80218 | Denver | Colorado |
| Avenzo Therapeutics Recruiting Site | 32827 | Orlando | Florida |
| Avenzo Therapeutics Recruiting Site | 34232 | Sarasota | Florida |
| Avenzo Therapeutics Recruiting Site | 75039 | Dallas | Texas |
| Avenzo Therapeutics Recruiting Site | 77054 | Houston | Texas |
| Avenzo Therapeutics Recruiting Site | 78229 | San Antonio | Texas |
| Avenzo Therapeutics Recruiting Site | 84119 | West Valley City | Utah |
| Avenzo Therapeutics Recruiting Site | 22031 | Fairfax | Virginia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.