RecruitingPhase 1Phase 2NCT05267626

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Sponsor

Aulos Bioscience, Inc.

Enrollment

159 participants

Start Date

Apr 4, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Cancer Cutaneous Melanoma

Summary

This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing AU-007, a new antibody drug designed to help the immune system fight advanced or metastatic cancers including melanoma, lung cancer, kidney cancer, and others. **You may be eligible if...** - You have advanced cancer that cannot be surgically removed, or that has spread to other parts of the body - Your cancer can be measured on imaging (CT or MRI) - For melanoma: your cancer has progressed after prior immunotherapy - For lung cancer: your tumor tests positive for PD-L1 and has no certain genetic mutations - For kidney cancer: you have progressed after prior immunotherapy **You may NOT be eligible if...** - You have not tried prior standard treatments for your cancer type - You have uncontrolled brain metastases - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAU-007

Monoclonal Antibody Targeting IL-2

DRUGAldesleukin

IL-2

DRUGAvelumab

Monoclonal Antibody Targeting PD-L1

DRUGNivolumab

Monoclonal Antibody Targeting PD-1

Locations(18)

Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

START Midwest

Grand Rapids, Michigan, United States

Minnesota Oncology and Hematology PA

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Atlantic Healthcare System

Morristown, New Jersey, United States

Carolina Biooncology Institute

Huntersville, North Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology (Balcones) - SCRI

Austin, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

Southside Cancer Care Centre

Miranda, New South Wales, Australia

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Sunshine Hospital

Saint Albans, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05267626

Related Trials

Study in Advanced Solid Tumor Patients

NCT0730094311 locations

A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

NCT0683300813 locations

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies

NCT0721383011 locations

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

NCT0614703715 locations

HEC169096 in Participants With Advanced Solid Tumors

NCT054516021 location