Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Sponsor: Avenzo Therapeutics, Inc.
ClinicalTrials ID:NCT07193511
This Phase 1/2 trial evaluates AVZO-103's safety, tolerability, and antitumor activity in patients with advanced/metastatic urothelial cancer or other solid tumors. Phase 1 focuses on dose escalation to determine the MTD and RP2D, while Phase 2 assesses efficacy. Eligible adults must have ECOG ≤ 1, measurable disease, and provide molecular test results. Interventions include AVZO-103 and a combination agent.
Patient Parameters
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Program Overview
This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.
Description
Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-103 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-103 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-103 as a monotherapy and in combination therapy.
Eligibility Criteria
Inclusion Criteria
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Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of > 3 months.
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Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:
o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).
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Measurable disease as assessed by Investigator using RECIST v1.1.
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Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.
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Other protocol-defined Inclusion criteria apply.
Key
Exclusion Criteria
- 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.
- Prior Stevens-Johnson syndrome/toxic epidermal necrolysis.
- 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 allogenic stem cell or solid organ transplant.
- Other protocol-defined Exclusion criteria apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Avenzo Therapeutics Recruiting Site | 32827 | Orlando | Florida |
| Avenzo Therapeutics Recruiting Site | 29572 | Myrtle Beach | South Carolina |
| Avenzo Therapeutics Recruiting Site | 37203 | Nashville | Tennessee |
| Avenzo Therapeutics Recruiting Site | 78758 | Austin | Texas |
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