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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1, monotherapy | Experimental | Part A |
|
| Phase 1, combination | Experimental | Part B |
|
| Phase 2, monotherapy | Experimental | Part A |
|
| Phase 2, combination | Experimental | Part B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVZO-103 | Drug | Specific dose in protocol specified schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) | Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level. | Approximately 2 years |
| Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1) | Approximately 16 months | |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) | From baseline until end of study treatment or study completion (approximately 2 years) | |
| Objective Response Rate (ORR) (Phase 2) | Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | From baseline through disease progression or study completion (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Phase 1) | From baseline through disease progression or study completion (approximately 2 years) | |
| Duration of Response (DOR) (Phase 1 and 2) | Defined as the time from the first confirmed response to radiologic/objective progression. |
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Key Inclusion Criteria:
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.
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).
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | (858) 239-2944 | ClinicalTrials@avenzotx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avenzo Therapeutics Recruiting Site | Recruiting | San Francisco | California | 94158 | United States | |
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| Combination Agent | Drug | Per label based on combination agent used |
|
| From baseline through disease progression or study completion (approximately 2 years) |
| Disease Control Rate (DCR) (Phase 1 and 2) | Defined as the proportion of patients who achieve tumor response (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD. | From baseline through disease progression or study completion (approximately 2 years) |
| Progression Free Survival (PFS) (Phase 1 and 2) | Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | From baseline through time to event on study or study completion (approximately 2 years) |
| Overall Survival (OS) (Phase 1 and 2) | Defined as the time from study drug treatment initiation to death from any cause. | Approximately 76 months |
| PK Parameters: Maximum observed concentration (Cmax) (Phase 1) | Up to 2 years |
| PK Parameters: Minimum observed concentration (Cmin) (Phase 1) | Up to 2 years |
| PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1) | Up to 2 years |
| PK Parameters: Elimination half-life (T1/2) (Phase 1) | Up to 2 years |
| PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1) | Up to 2 years |
| PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1) | Up to 2 years |
| PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCĪ) (Phase 1) | Up to 2 years |
| PK Parameters: Apparent Clearance (CL/F) (Phase 1) | Up to 2 years |
| PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1) | Up to 2 years |
| PK Parameters: Accumulation ratio (AR) (Phase 1) | Up to 2 years |
| Determination of RP2D (Phase 2) | Approximately 16 months |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2) | From baseline until end of study treatment or study completion (approximately 2 years) |
| Avenzo Therapeutics Recruiting Site |
| Recruiting |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Orlando | Florida | 32827 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Tampa | Florida | 33612 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Boston | Massachusetts | 02114 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | New York | New York | 10065 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Nashville | Tennessee | 37203 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Austin | Texas | 78758 | United States |
| Avenzo Therapeutics Recruiting Site | Recruiting | Irving | Texas | 75039 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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