Phase 1 Study of Intravenous PRT1419 in Patients with Advanced Solid Tumors — PRT1419-02 (NCT04837677)
Intervention:
Intravenous PRT1419
Trial Status:
Actively Recruiting
Trial Information:
PRT1419 is designed to be a potent, selective inhibitor of the anti-apoptotic protein, myeloid cell leukemia 1 (MCL1) administered by intravenous (IV) injection. MCL1 has been shown to have a critical role in promoting cancer cell survival and is frequently found to be amplified or overexpressed in both solid tumors and hematologic cancers.
This Phase 1 dose-escalation study of PRT1419 will seek to define the dosing schedule, maximally tolerated dose, and/or estimate the optimal biological dose to be used in subsequent development of PRT1419. Prelude is advancing the intravenous formulation of PRT1419 in combination with venetoclax to rapidly establish proof-of-concept in myeloid malignancies. Provided this combination is well-tolerated, Prelude anticipates that PRT1419 has the potential to be a best-in-class MCL1 inhibitor.
The study will enroll patients with certain relapsed/refractory hematologic malignancies, including: High-risk myelodysplastic syndrome (MDS) and Acute myeloid leukemia (AML).
For full trial information, please visit ClinicalTrials.gov or contact us directly at [email protected].
Phase 1 Study of Intravenous PRT1419 in Patients with Relapsed/Refractory Hematologic Malignancies — PRT1419-03 (NCT05107856)
Intervention:
Intravenous PRT1419
Trial Status:
Actively Recruiting
Trial Information:
PRT1419 is designed to be a potent, selective inhibitor of the anti-apoptotic protein, myeloid cell leukemia 1 (MCL1) administered by intravenous (IV) injection. MCL1 has been shown to have a critical role in promoting cancer cell survival and is frequently found to be amplified or overexpressed in both solid tumors and hematologic cancers.
This Phase 1 dose-escalation study of PRT1419 will seek to define the dosing schedule, maximally tolerated dose, and/or estimate the optimal biological dose to be used in subsequent development of PRT1419. Prelude is advancing the intravenous formulation of PRT1419 in combination with venetoclax to rapidly establish proof-of-concept in myeloid malignancies. Provided this combination is well-tolerated, Prelude anticipates that PRT1419 has the potential to be a best-in-class MCL1 inhibitor.
The study will enroll patients with certain relapsed/refractory hematologic malignancies, including: High-risk myelodysplastic syndrome (MDS) and Acute myeloid leukemia (AML).
For full trial information, please visit ClinicalTrials.gov or contact us directly at [email protected].