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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

NCT ID: NCT07193511

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-02

Study Completion Date

2030-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Solid Tumor Cancer Locally Advanced Metastatic Solid Tumors Urothelial Cancer

Keywords

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Solid Tumors Metastatic Locally Advanced Urothelial Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1, monotherapy

Part A

Group Type EXPERIMENTAL

AVZO-103

Intervention Type DRUG

Specific dose in protocol specified schedule

Phase 1, combination

Part B

Group Type EXPERIMENTAL

AVZO-103

Intervention Type DRUG

Specific dose in protocol specified schedule

Combination Agent

Intervention Type DRUG

Per label based on combination agent used

Phase 2, monotherapy

Part A

Group Type EXPERIMENTAL

AVZO-103

Intervention Type DRUG

Specific dose in protocol specified schedule

Phase 2, combination

Part B

Group Type EXPERIMENTAL

AVZO-103

Intervention Type DRUG

Specific dose in protocol specified schedule

Combination Agent

Intervention Type DRUG

Per label based on combination agent used

Interventions

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AVZO-103

Specific dose in protocol specified schedule

Intervention Type DRUG

Combination Agent

Per label based on combination agent used

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avenzo Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Avenzo Therapeutics Recruiting Site

Orlando, Florida, United States

Site Status RECRUITING

Avenzo Therapeutics Recruiting Site

Myrtle Beach, South Carolina, United States

Site Status RECRUITING

Avenzo Therapeutics Recruiting Site

Nashville, Tennessee, United States

Site Status RECRUITING

Avenzo Therapeutics Recruiting Site

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical Information

Role: CONTACT

Phone: (858) 239-2944

Email: [email protected]

Other Identifiers

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AVZO-103-1001

Identifier Type: -

Identifier Source: org_study_id