Full TitleADCT-502-101: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-502 in Patients with Advanced Solid Tumors with HER2 Expression
ADCT-502 is an investigational therapy called an “antibody-drug conjugate.” This means it contains an antibody (trastuzumab, which binds to a protein on some cancer cells called HER2) and a drug that is ferried to the cancer cell by the antibody (the drug is called SG3199).
In this study, researchers want to find the highest dose of ADCT-502 that can be given safely in patients with solid tumors that are positive for HER2 and cannot be successfully treated with other therapies that target HER2. ADCT-502 is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a solid tumor that is positive for HER2 and has continued to grow despite treatments that target HER2, or the patient could not tolerate the side effects of these treatments. Examples include breast cancer and stomach cancer.
- At least 3 weeks must pass between the completion of previous therapy and entry into the study.
- For the dose-escalation part of the study: Patients must be able to walk and do routine activities for more than half of their normal waking hours. For the dose-expansion part of the study: Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Komal Jhaveri at 646-888-5157 or Courtnee Depass at 646-888-4425.