A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination with Pembrolizumab in Patients with Solid Tumors
Study of NDI-101150 Alone or in Combination with Pembrolizumab in Patients with Solid Tumors
Sponsor: Nimbus Saturn Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU6332
U.S. Govt. ID: NCT05128487
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to find out if a new investigational drug NDI-101150 is safe when given alone and in combination with pembrolizumab, and to look at the pharmacokinetics (PK, to measure how your body takes up, breaks down, and clears NDI-101150) and the antitumor activity (to measure how NDI-101150 works in your tumors). Investigational means the drug has not been approved by the Food and Drug Administration (FDA). This is the first time that NDI-101150 is being tested in humans. NDI-101150 is a small molecule inhibitor of HPK1 (a protein that weakens the immune system). It is highly specific to HPK1 and has limited activity towards other proteins. Pembrolizumab is an FDA-approved agent for multiple types of tumors. Pembrolizumab binds to and blocks PD-1 located on lymphocytes (white blood cells). NDI-101150 given alone may boost immune responses and inhibit tumor growth. NDI-101150 when combined with pembrolizumab may decrease the size of tumors. Cancers include: bladder cancer, breast cancer, colon and rectal cancer, esophageal cancer, gynecologic cancers, kidney cancer, leukemia, liver cancer, lung cancer, Non-Hodgkin's lymphoma, pancreatic cancer, prostate cancer, stomach cancer, testicular cancer, and thyroid cancer.
Do You Qualify?
Are you at least 18 years old? Yes No
Do you have a life expectancy of more than 12 weeks? Yes No
You may be eligible for this study

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