Description:
This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with
advanced cancers who have exhausted available treatment options. The purpose of this study is
to define a safe dose and schedule to be used in subsequent development of PRT543.
Title
- Brief Title: A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
- Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Clinical Trial IDs
- ORG STUDY ID:
PRT543-01
- NCT ID:
NCT03886831
Conditions
- Relapsed/Refractory Advanced Solid Tumors
- Relapsed/Refractory Diffuse Large B-cell Lymphoma
- Relapsed/Refractory Myelodysplasia
- Relapsed/Refractory Myelofibrosis
- Adenoid Cystic Carcinoma
- Relapsed/Refractory Mantle Cell Lymphoma
- Relapsed/Refractory Acute Myeloid Leukemia
- Refractory Chronic Myelomonocytic Leukemia
Interventions
| Drug | Synonyms | Arms |
|---|
| PRT543 | | PRT543 |
Purpose
This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with
advanced cancers who have exhausted available treatment options. The purpose of this study is
to define a safe dose and schedule to be used in subsequent development of PRT543.
Detailed 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 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 ten 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| PRT543 | Experimental | PRT543 will be administered orally | |
Eligibility Criteria
Inclusion Criteria:
- Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or
advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid
leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All
malignancies must be refractory to established therapies
- Biomarker-selected solid tumors
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
- Female patients of childbearing potential must have a negative pregnancy test within 7
days of the start of treatment and must agree to use an effective method of
contraception during the trial
Exclusion Criteria:
- Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases
- Requirement of pharmacologic doses of glucocorticoids
- Prior treatment with chimeric antigen receptor T cells (CAR-T cells)
- HIV positive; known active hepatitis B or C
- Known hypersensitivity to any of the components of PRT543
- Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less
than 100 days since transplantation
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | To describe dose limiting toxicities (DLT) of PRT543 |
| Time Frame: | Baseline through Day 28. |
| Safety Issue: | |
| Description: | Dose limiting toxicities (DLTs) will be evaluated during the first cycle |
Secondary Outcome Measures
| Measure: | To describe the adverse event profile and tolerability of PRT543 |
| Time Frame: | Baseline through approximately 2 years |
| Safety Issue: | |
| Description: | Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy |
| Measure: | To determine the maximum observed plasma concentration (Cmax) of PRT543 |
| Time Frame: | Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. |
| Safety Issue: | |
| Description: | PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration. |
| Measure: | To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543 |
| Time Frame: | Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. |
| Safety Issue: | |
| Description: | PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Prelude Therapeutics |
Trial Keywords
Last Updated
July 30, 2021
