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PRT1419

Phase 1

Multiple Myeloma | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Mar 15, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

PRT1419 · 2 trials · 11 indications

Phase 1 2
NCT04837677A Study of PRT1419 in Patients With Advanced Solid TumorsSarcoma
COMPLETED26 Analytics
NCT04543305A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic MalignanciesMultiple Myeloma
COMPLETED16 Analytics
PHASE1COMPLETED
A Study of PRT1419 in Patients With Advanced Solid Tumors
SarcomaUnlock trial analytics
PHASE1COMPLETED
A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose limiting toxicities (DLT) of PRT1419
Baseline through Day 28

Dose limiting toxicities will be evaluated through the first cycle

Maximally tolerated dose (MTD) and/or optimal biological dose (OBD)
Baseline through approximately 2 years

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

Recommended phase 2 dose (RP2D) and schedule of PRT1419
Baseline through approximately 2 years

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

To describe dose limiting toxicities (DLT) of PRT1419
Baseline through Day 28

Dose limiting toxicities will be evaluated through the first cycle

To determine the maximally tolerated dose (MTD) and/or optimal biological dose (OBD)
Baseline through approximately 2 years

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

To determine the recommended phase 2 dose (RP2D) and schedule of PRT1419
Baseline through approximately 2 years

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

Secondary Endpoints

Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments
Baseline through approximately 2 years
Pharmacokinetic profile of PRT1419: maximum observed plasma concentration
Baseline through approximately 2 years
Anti-tumor activity of PRT1419: measurement of objective responses
Baseline through approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PRT1419EXPERIMENTALPRT1419 will be administered by intravenous infusion

Interventions

NameTypeDescription
PRT1419DRUGPRT1419 will be administered by intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Adequate organ function (bone marrow, hepatic, renal, cardiovascular) * Left ventricular ejection fraction of ≥ 50% * Female patients of childbearing potential must have a negative pregnancy test within 7 da...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about PRT1419

What is PRT1419 used for?

PRT1419 is an investigational small molecule being studied for the treatment of relapsed or refractory hematologic malignancies, including multiple myeloma, acute myeloid leukemia, non-Hodgkin lymphoma, and myelodysplastic syndromes, as well as advanced solid tumors such as sarcoma, melanoma, lung cancer, breast cancer, esophageal cancer, cervical cancer, and head and neck cancer.

Who makes PRT1419?

PRT1419 is being developed by Prelude Therapeutics Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol PRLD.

What phase is PRT1419 in?

PRT1419 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 studies have been completed, one in hematologic malignancies and one in advanced solid tumors.

What clinical trials is PRT1419 in?

PRT1419 has been studied in two completed Phase 1 clinical trials. NCT04543305 evaluated PRT1419 in patients with relapsed or refractory hematologic malignancies, enrolling 16 participants. NCT04837677 evaluated PRT1419 in patients with advanced solid tumors, enrolling 26 participants. Both trials were conducted in the United States.

Is PRT1419 the same as any other drug?

PRT1419 is a distinct investigational compound and is not known to be the same as any other approved or marketed drug. It is being developed by Prelude Therapeutics under its own unique identifier.