A Phase 1b Multicenter Study to Determine the Dose Safety Efficacy and Pharmacokinetics of TRK-950 when Used in Combinations with Selected Anti-Cancer Treatment Regimens in Patients with Selected Advanced Solid Tumors.

Brief description of study

The purpose of the study is to evaluateTRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions 7) Bevacizumab or 8) Nivolumab / Ipilimumab 9) Gemcitabine/carboplatin/bevacizumab (platinum sensitive ovary cancer) 10) PLD or topotecan (platinum resistant ovary cancer) in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.


Clinical Study Identifier: s21-00815
ClinicalTrials.gov Identifier: NCT03872947
Principal Investigator: Bhavana Pothuri.
Other Investigators: Kent Chan, Amanda Shepherd-Littlejohn, Jaime Lynn Moyles, Deanna Gerber, Eva Chalas-Westermann, Shun Yu, Theresa Ryan, Marina Stasenko, Cristian C Papazoglu Statescu, Fabia Brisard Pierrot, Nina Beri, Paul E. Oberstein, Caitlin Elizabeth Ryan, Kathleen M Lutz, Leslie R Boyd, Christina Grace Wilson, Jennifer Wu, Michelle Diane Swanson Lightfoot, Whitfield B. Growdon, Jennifer Chuy, Lawrence P Leichman, Mary Lynn R Nierodzik, Edna Shifteh, Daniel J Becker, Edward A Jimenez, Erin Annette Reese, Vania R. Baudin, Kelly A Levine, Alexander A Hindenburg.


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