Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

Avenzo Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lung Cancers; Solid Tumor Cancer; Locally Advanced; Epithelial Tumor; Metastatic Solid Tumors

Treatments: Drug: Combination Agent 2; Drug: AVZO-1418; Drug: Combination Agent 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07038343

AVZO-1418-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

430 participants in 4 patient groups

Phase 1, monotherapy

Experimental group

Description:

Group A

Treatment:

Drug: AVZO-1418

Phase 1, combination

Experimental group

Description:

Group B

Treatment:

Drug: Combination Agent 1

Drug: AVZO-1418

Drug: Combination Agent 2

Phase 2, monotherapy

Experimental group

Description:

Part A

Treatment:

Drug: AVZO-1418

Phase 2, combination

Experimental group

Description:

Part B

Treatment:

Drug: Combination Agent 1

Drug: AVZO-1418

Drug: Combination Agent 2