Recruiting PHASE1, PHASE2 Solid Tumor Cancer

New treatment option for Solid Tumor Cancer

Official title BEACON-1: 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)

ClinicalTrials.gov ID: NCT07193511

What this study is testing

What is AVZO-103?

AVZO-103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications: o Locally...
  • 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 apply. Key

You likely can't join if

  • Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may...
  • 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.
See the full eligibility criteria
Who can join
  • 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...
  • 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 apply. Key
What rules you out
  • 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...
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Myrtle Beach, South Carolina, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Irving, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Francisco, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.