AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат AVZO-1418
  Specific dose in protocol specified schedule
• Препарат Combination Agent 1
  Per label based on combination agent used
• Препарат Combination Agent 2
  Per label based on combination agent used

Первичные конечные точки

• Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) [Срок оценки: Approximately 2 years]
• Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1) [Срок оценки: Approximately 16 months]
• Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) [Срок оценки: From baseline until end of study treatment or study completion (approximately 2 years)]
• Objective Response Rate (ORR) (Phase 2) [Срок оценки: From baseline through disease progression or study completion (approximately 2 years)]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) (Phase 1) [Срок оценки: From baseline through disease progression or study completion (approximately 2 years)]
• Duration of Response (DOR) (Phase 1 and 2) [Срок оценки: From baseline through disease progression or study completion (approximately 2 years)]
• Disease Control Rate (DCR) (Phase 1 and 2) [Срок оценки: From baseline through disease progression or study completion (approximately 2 years)]
• Progression Free Survival (PFS) (Phase 1 and 2) [Срок оценки: From baseline through time to event on study or study completion (approximately 2 years)]
• Overall Survival (OS) (Phase 1 and 2) [Срок оценки: Approximately 76 months]
• PK Parameters: Maximum observed concentration (Cmax) (Phase 1) [Срок оценки: Up to 2 years]
• PK Parameters: Minimum observed concentration (Cmin) (Phase 1) [Срок оценки: Up to 2 years]
• PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1) [Срок оценки: Up to 2 years]
• PK Parameters: Elimination half-life (T1/2) (Phase 1) [Срок оценки: Up to 2 years]
• PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1) [Срок оценки: Up to 2 years]
• PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1) [Срок оценки: 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) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 18 центров

• Avenzo Therapeutics Recruiting Site — Gilbert
• Avenzo Therapeutics Recruiting Site — Los Angeles
• Avenzo Therapeutics Recruiting Site — Denver
• Avenzo Therapeutics Recruiting Site — New Haven
• Avenzo Therapeutics Recruiting Site — Washington D.C.
• Avenzo Therapeutics Recruiting Site — Orlando
• Avenzo Therapeutics Recruiting Site — Sarasota
• Avenzo Therapeutics Recruiting Site — Tampa
• … и ещё 10 центров

Идентификаторы

NCT: NCT07038343 · AVZO-1418-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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