A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Advanced Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open label, dose escalationMasking: None (Open Label)Masking Description: None, open labelPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Dose-escalation Phase Eligible patients will receive FF-10832 in 28 day cycles. Dosing will continue until progression of disease, observation of unacceptable adverse events, intercurrent illness, or changes in the patient's condition that prevents further study participation after discussion betwee...
Dose-escalation Phase Eligible patients will receive FF-10832 in 28 day cycles. Dosing will continue until progression of disease, observation of unacceptable adverse events, intercurrent illness, or changes in the patient's condition that prevents further study participation after discussion between the Investigator and the Medical Monitor. A number of cohorts will be enrolled sufficient to determine the MTD and to identify the RP2D. Expansion Phase Once 6 patients are treated at the MTD or RP2D in each regimen during the dose-escalation phase, it is anticipated that up to three additional cohorts, distributed among the regimens, may enroll up to 12 patients each.
Tracking Information
- NCT #
- NCT03440450
- Collaborators
- Not Provided
- Investigators
- Not Provided
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