Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Breast Neoplasms

Melanoma

Head and Neck Neoplasms

Sarcoma

Lung Neoplasms

Esophageal Cancer

Soft Tissue Sarcoma

PRT1419 will be administered by intravenous infusion

PRT1419

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients with relapsed or refractory solid tumors, including breast, lung, sarcoma and melanoma as part of a 28-day treatment cycle. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.

A Study of PRT1419 in Patients With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors

Dose limiting toxicities will be evaluated through the first cycle

The MTD and/or OBD will be established for further investigation in participants with advanced solid tumors.

The RP2D will be established for further investigation in participants with advanced solid tumors.

Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)

PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration

Anti-tumor activity of PRT1419 will be based on the measurement of objective responses

Progression-free survival will be calculated from the first administration of PRT1419 until death or until the criteria for disease progression are met

Prelude Therapeutics

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Lymphosarcoma

Acute Graft Versus Host Disease

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with relapsed/refractory hematologic malignancies. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients in two cohorts as part of a 28-day treatment cycle in adult patients with multiple myeloma (MM), non-Hodgkin's lymphoma (NHL), acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), high-risk myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) overlap syndrome. Cohort A will evaluate PRT1419 administered as monotherapy in patients with either AML, CMML and/or high-risk MDS or MDS/MPN overlap. Cohort B will evaluate PRT1419 administered as monotherapy in patients with NHL or MM. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.

A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies

The MTD and/or OBD will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome

The RP2D will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome

Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of PRT1419 in Patients With Advanced Solid Tumors	NCT04837677	Sarcoma Melanoma Lung Cancer Breast Cancer Esophageal Canc... Cervical Cancer Head and Neck C...	PRT1419	18 Years -	Prelude Therapeutics
A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies	NCT04543305	Multiple Myelom... Acute Myeloid L... Non Hodgkin Lym... Myelodysplastic...	PRT1419	18 Years -	Prelude Therapeutics
A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies	NCT04543305	Multiple Myelom... Acute Myeloid L... Non Hodgkin Lym... Myelodysplastic...	PRT1419	18 Years -	Prelude Therapeutics

Spots Global Cancer Trial Database for prt1419

Every month we try and update this database with for prt1419 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prt1419

Every month we try and update this database with for prt1419 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prt1419 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.