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 (AVZO-103-1001)

Avenzo Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor Cancer; Locally Advanced; Urothelial Cancer; Metastatic Solid Tumors

Treatments: Drug: Combination Agent; Drug: AVZO-103

Study type: Interventional

Funder types: Industry

Identifiers

NCT07193511

AVZO-103-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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355 participants in 4 patient groups

Phase 1, monotherapy

Experimental group

Description:

Part A

Treatment:

Drug: AVZO-103

Phase 1, combination

Experimental group

Description:

Part B

Treatment:

Drug: AVZO-103

Drug: Combination Agent

Phase 2, monotherapy

Experimental group

Description:

Part A

Treatment:

Drug: AVZO-103

Phase 2, combination

Experimental group

Description:

Part B

Treatment:

Drug: AVZO-103

Drug: Combination Agent