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
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 or 8) Nivolumab / Ipilimumab 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,
Cindy Corbo,
Deanna Gerber,
Eva Chalas-Westermann,
Shun Yu,
Mary Lynn R Nierodzik,
Theresa Ryan,
Marina Stasenko,
Cristian C Papazoglu Statescu,
Olivia Richardson Khouri,
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,
Victoria Helen Dowd,
Daniel J Becker,
Edward A Jimenez,
Erin Annette Reese,
Kelly A Levine,
Alexander A Hindenburg.
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