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A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors

What is this study?

This study is testing a new experimental medicine called IKS014 for patients with certain advanced cancers, including breast, stomach, or esophageal cancer. The goal is to see how safe the drug is and to find the right dose to help fight tumors that have a protein called HER2.

Who can participate?

This trial is for adults with advanced cancers that express the HER2 protein. You may be eligible if you have previously tried specific treatments like CDK4/6 inhibitors and meet certain requirements for your blood counts, though you must not have specific lung or eye conditions.

What will happen?

Participants will receive the experimental drug IKS014 and will be closely monitored by the medical team to check for side effects and how their body reacts to the treatment. This helps researchers determine the safest and most effective dose for future patients.

Where and when?

This study is currently recruiting volunteers at locations in Newport Beach, California; Boston, Massachusetts; and Nashville, Tennessee.

Key Points
  • 1The study tests an experimental antibody-drug conjugate designed to target HER2-positive cancer cells.
  • 2Researchers are focused on finding the best dose while carefully checking for safety and side effects.
  • 3Potential participants must meet specific health criteria, including healthy lung and eye function, to be eligible.

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Conditions Studied
This study is investigating treatments for the following conditions
Breast CancerGastric CancerGastroesophageal-junction Cancer

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.