What is AVZO-1418 studying for locally advanced or metastatic solid tumors?

AVZO-1418 is being studied to evaluate its safety, how it is processed by the body, and its potential antitumor activity in patients with locally advanced or metastatic epithelial solid tumors. This research aims to find safe dosing and assess its effects alone or in combination with other therapies under the sponsorship of Avenzo Therapeutics, Inc.

Who may be eligible for this locally advanced or metastatic solid tumor clinical trial?

Adults aged 18 to 75 with confirmed locally advanced or metastatic epithelial solid tumors may be eligible. Participants need a good performance status and measurable disease. People with uncontrolled hypertension or active brain metastases are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this locally advanced or metastatic solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID07038343

A Phase 1/2 Study to Assess Safety, Tolerability, and Antitumor Activity of AVZO-1418 Alone and With Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors

Led by Avenzo Therapeutics, Inc. · Updated on 2026-05-13

480

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying AVZO-1418 in patients with locally advanced or metastatic epithelial solid tumors to understand its safety, how the body processes it, and its potential antitumor effects. This first-in-human Phase 1/2 trial aims to find the highest safe dose and assess preliminary benefits when given alone or with other treatments. The study has two main parts: Phase 1 focuses on gradually increasing doses of AVZO-1418 to determine safety and the best dose for further study, both as a single agent and possibly combined with other drugs. Phase 2 expands on this by evaluating how well AVZO-1418 works alone or with combination therapies. Treatments are given intravenously according to specific schedules outlined in the protocol. Participants will be monitored closely for side effects, drug levels in the body, and tumor response using established measures over approximately two years. Researchers will collect data through clinical exams, laboratory tests, imaging scans, and safety assessments. Long-term survival and other outcomes will also be tracked to better understand the treatment's effects and tolerability.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 75 years with ECOG Performance Status of 0 or 1 and life expectancy over 3 months
Histologically or cytologically confirmed locally advanced or metastatic epithelial solid tumors as specified in the protocol
Measurable disease based on RECIST v1.1 criteria
Agree to provide molecular test results and tumor samples or fresh biopsy as applicable
Meet other protocol-defined inclusion criteria

You will not qualify if you...

Uncontrolled hypertension
Active central nervous system metastases; asymptomatic and treated brain metastases allowed if stable for at least 4 weeks without steroid treatment
Suspected or confirmed leptomeningeal disease
History of drug-induced interstitial lung disease
History of serious cardiovascular conditions
Infection requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before first dose
History of solid organ transplant
Meet other protocol-defined exclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 2 years or until disease progression or study completion

Participants receive AVZO-1418 alone or in combination with other therapies to assess safety, tolerability, and antitumor activity.

Visits occur throughout treatment as per protocol schedule

Follow-up

Duration - Up to approximately 76 months

Participants are monitored after treatment for safety and survival outcomes.

Periodic visits as scheduled by the study