A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Adenoid Cystic Carcinoma
- Refractory Chronic Myelomonocytic Leukemia
- Relapsed/Refractory Acute Myeloid Leukemia
- Relapsed/Refractory Advanced Solid Tumors
- Relapsed/Refractory Diffuse Large B-cell Lymphoma
- Relapsed/Refractory Mantle Cell Lymphoma
- Relapsed/Refractory Myelodysplasia
- Relapsed/Refractory Myelofibrosis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and...
This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). The study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion part involving up to nine separate cohorts. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT543.
Tracking Information
- NCT #
- NCT03886831
- Collaborators
- Not Provided
- Investigators
- Not Provided
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