Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination with Pembrolizumab or Chemotherapy in Patients with Lymphoma or Solid Tumor Malignancies
Study of TTX-030 Alone and in Combination with Pembrolizumab or Chemotherapy in Subjects with Lymphoma or Solid TUmor Malignancies
Sponsor: Tizona Therapeutics
Enrolling: Male and Female Patients
IRB Number: AAAS3111
U.S. Govt. ID: NCT03884556
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to find answers to the following research questions: 1. What is the highest dose of TTX-030 that can be given to subjects when given as an intravenous (IV through a needle into your vein) over a 30 minute period once every 3 weeks (for Arms 1-3) or once every 2 weeks (for Arm 4)? 2. What are the side effects of TTX-030 when given alone or in combination with either of the commercially approved agents? 3. How much TTX-030 is in the blood at specific times after dosing and how does the body get rid of the TTX-030? TTX-030 is a drug that impacts a pathway on the surface of cells called the adenosine pathway, by inhibiting a receptor called CD39. Cancer cells use this pathway as an important way to suppress the bodys immune system response and create and maintain a positive tumor environment. TTX-030 changes the pathway and promotes your bodys anti-tumor immune system response. TTX-030 has slowed the growth and/or shrank several types of cancers in animals. It is hoped that by taking TTX-030 the growth of your tumor will be slowed or will shrink, but TTX-030 has never been tested in humans. Although animal studies suggest that it may be helpful in humans, its effectiveness is not known. Cancers may include: bladder cancer, breast cancer, lung cancer, stomach cancer, colon cancer, rectal cancer, head and neck cancer, oral cancer, liver cancer, and melanoma.
This study is closed
Investigator
Emerson Lim, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Have you been diagnosed with one of the cancers listed in the description? Yes No
Have all of the adverse (side) effects of your prior therapies been resolved? Yes No
Are you able to perform everyday work independently? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162