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Brief Title: A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
Official Title: 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
Study ID: NCT03872947
Brief Summary: The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Pegylated liposomal doxorubicin (PLD), Carboplatin / PLD / Bevacizumab and Paclitaxel for selected advanced solid tumors.
Detailed Description: This study is an open-label, Phase 1b study evaluating TRK-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 8) Gemcitabine / Carboplatin / Bevacizumab, 9)PLD, 10) Carboplatin / PLD / Bevacizumab or 11) Paclitaxel 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research Institute, Scottsdale, Arizona, United States
AOA-HOPE, Tucson, Arizona, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
HOAG Memorial Hospital Presbyterian, Newport, California, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Atlantic Health System, Morristown, New Jersey, United States
Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center), Eugene, Oregon, United States
Northwest Cancer Specialists, Portland, Oregon, United States
Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Downtown Fort Worth Cancer Center, Fort Worth, Texas, United States
Virginia Cancer Specialists, PC, Leesburg, Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Centre Léon Bérard, Lyon, , France