Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
Purpose
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
- Solid Tumor Cancer
- Locally Advanced
- Metastatic Solid Tumors
- Lung Cancers
- Epithelial Tumor
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1, monotherapy |
Group A |
|
|
Experimental Phase 1, combination |
Group B |
|
|
Experimental Phase 2, monotherapy |
Part A |
|
|
Experimental Phase 2, combination |
Part B |
|
Recruiting Locations
Denver 5419384, Colorado 5417618 80218
Avenzo Therapeutics
Orlando 4167147, Florida 4155751 32827
Avenzo Therapeutics
Sarasota 4172131, Florida 4155751 34232
Avenzo Therapeutics
Philadelphia 4560349, Pennsylvania 6254927 19107
Avenzo Therapeutics
Dallas 4684888, Texas 4736286 75039
Avenzo Therapeutics
Houston 4699066, Texas 4736286 77054
Avenzo Therapeutics
San Antonio 4726206, Texas 4736286 78229
Avenzo Therapeutics
West Valley City 5784607, Utah 5549030 84119
Avenzo Therapeutics
Fairfax 4758023, Virginia 6254928 22031
Avenzo Therapeutics
More Details
- Status
- Recruiting
- Sponsor
- Avenzo Therapeutics, Inc.
Detailed Description
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.