A Phase 1 Study of DAY301 in People With Advanced Solid Tumors

Full Title

A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients with Locally Advanced or Metastatic Solid Tumors

Purpose

Researchers want to find the best dose of DAY301 to give to people with advanced solid tumors. The people in this study have solid tumors that have spread beyond their original location, including:

  • Head and neck cancer
  • Cancers of the esophagus, stomach, and gastroesophageal junction 
  • Non-small cell lung cancer and small cell lung cancer
  • Gynecologic cancers: ovarian, endometrial, and cervical
  • Triple-negative breast cancer

DAY301 is a type of drug called an antibody-drug conjugate (ADC). ADCs are substances made up of a monoclonal antibody (special protein) linked to a drug. The antibody binds to specific proteins on certain types of cells, including cancer cells. The linked drug enters these cells and kills them. With ADCs, there is a lower risk of harming normal cells, since they usually do not have the target protein.

DAY301 targets cells with a protein called PTK7, which plays a role in cancer growth. By destroying these cells, DAY301 may help slow or stop the growth of your cancer. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have one of the advanced solid tumors listed above, which has spread beyond its original location.
  • Have completed prior anti-cancer therapy at least 4 weeks before getting DAY301.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Robert Maki’s office at 646-888-5059.

Protocol

25-112

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06752681