Phase 1 Study of Oral TP-1454
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Open labelMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454 monotherapy in patients with advanced metastatic solid tumors To establish the MTD and/or RP2D of orally administered TP-1454 in combination with ipilimumab and nivolumab in patients with ad...
Primary Objective: To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454 monotherapy in patients with advanced metastatic solid tumors To establish the MTD and/or RP2D of orally administered TP-1454 in combination with ipilimumab and nivolumab in patients with advanced/metastatic solid tumors whom the investigator deems appropriate for treatment with the defined regimen Secondary Objectives: To establish the pharmacokinetic (PK) profile of orally administered TP-1454 alone and in combination with ipilimumab and nivolumab To observe patients for any evidence of antitumor activity of TP 1454 alone and in combination with ipilimumab and nivolumab by objective radiographic assessment To study the safety of oral TP-1454 administered as monotherapy and in combination with ipilimumab and nivolumab in patients with advanced/metastatic solid tumors whom the investigator deems appropriate for treatment with the defined regimen
Tracking Information
- NCT #
- NCT04328740
- Collaborators
- Not Provided
- Investigators
- Study Director: Gregory Pennock, MD Sumitomo Dainippon Pharma Oncology, Inc
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