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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT543 | Experimental | PRT543 will be administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT543 | Drug | PRT543 will be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe dose limiting toxicities (DLT) of PRT543 | Dose limiting toxicities (DLTs) will be evaluated during the first cycle | Baseline through Day 28. |
| To determine the maximally tolerated dose (MTD) | The maximum tolerated dose (MTD) will be established for further investigation in participants with advanced malignancies who have failed prior treatments. | Baseline through approximately 2 years. |
| To determine the recommended phase 2 dose (RP2D) and schedule of PRT543 | The recommended phase 2 dose (RP2D) and optimal dosing schedule of PRT543 will be established for further investigation in participants with advanced malignancies who have failed prior treatments. | Baseline through approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the adverse event profile and tolerability of PRT543 | Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy | Baseline through approximately 2 years |
| To determine the maximum observed plasma concentration (Cmax) of PRT543 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the terminal elimination half-life (t1/2) of PRT543. | PRT543 pharmacokinetics will be calculated including the terminal elimination half life | Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| UCSF Precision Cancer Medicine Building |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38118249 | Derived | Ferrarotto R, Swiecicki PL, Zandberg DP, Baiocchi RA, Wesolowski R, Rodriguez CP, McKean M, Kang H, Monga V, Nath R, Palmisiano N, Babbar N, Sun W, Hanna GJ. PRT543, a protein arginine methyltransferase 5 inhibitor, in patients with advanced adenoid cystic carcinoma: An open-label, phase I dose-expansion study. Oral Oncol. 2024 Feb;149:106634. doi: 10.1016/j.oraloncology.2023.106634. Epub 2023 Dec 20. |
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PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration. |
| 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. |
| To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543 | PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration | 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. |
| To determine the area under the plasma concentration versus time curve (AUC) of PRT543 |
PRT543 pharmacokinetics will be calculated including area under the plasma concentration versus time curve. |
| Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: 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. |
| San Francisco |
| California |
| 94158 |
| United States |
| Christiana Care Health Services, Christiana Hospital | Newark | Delaware | 19718 | United States |
| Florida Cancer Specialists | Lake Mary | Florida | 32746 | United States |
| Florida Cancer Specialist | Sarasota | Florida | 34232 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Norton Cancer Institute, St. Matthews Campus | Louisville | Kentucky | 40207 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Atlantic Health System / Morristown Medical Center | Morristown | New Jersey | 07962 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| The Ohio State University and Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| PLLC | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D055728 | Primary Myelofibrosis |
| D003528 | Carcinoma, Adenoid Cystic |
| D020522 | Lymphoma, Mantle-Cell |
| D015470 | Leukemia, Myeloid, Acute |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
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