A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, andPreliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination withPembrolizumab in Patients with Solid Tumors
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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.
Are you Eligible? (Inclusion Criteria)
- You are ≥ 18 years of age - You have a life expectancy of ≥ 12 weeks - You are able to swallow and retain oral medications
