RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT07038343Sponsor: Avenzo Therapeutics, Inc.Last updated: 2026-05-13

Summary

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.

Detailed 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.

Arms & interventions

DrugAVZO-1418
Specific dose in protocol specified schedule
DrugCombination Agent 1
Per label based on combination agent used
DrugCombination Agent 2
Per label based on combination agent used

Outcome measures

Primary

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.
Time frame: Approximately 2 years
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)
Time frame: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Time frame: 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.
Time frame: From baseline through disease progression or study completion (approximately 2 years)

Secondary

Objective Response Rate (ORR) (Phase 1)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Disease Control Rate (DCR) (Phase 1 and 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and 2)
Time frame: From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and 2)
Time frame: Approximately 76 months
PK Parameters: Maximum observed concentration (Cmax) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Minimum observed concentration (Cmin) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Elimination half-life (T1/2) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Apparent Clearance (CL/F) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Accumulation ratio (AR) (Phase 1)
Time frame: Up to 2 years
Determination of RP2D (Phase 2)
Time frame: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No

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.