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PRT1419

Phase 1

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

PRT1419 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Sep 2020

PRT1419 target and mechanism

Molecular targetMCL-1
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment42

FDA Designations

No designations recorded

PRT1419 clinical trials

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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Frequently asked questions about PRT1419

What is PRT1419 used for?

PRT1419 is an investigational small molecule being studied in oncology for advanced solid tumors, including sarcoma, and for relapsed or refractory hematologic malignancies such as multiple myeloma. It is not approved for any indication and remains in clinical development.

What does PRT1419 target?

PRT1419 targets MCL-1, a protein in the BCL-2 family that regulates apoptosis. By inhibiting MCL-1, PRT1419 is designed to promote programmed cell death in cancer cells that depend on this protein for survival.

Who is developing PRT1419?

PRT1419 is being developed by Prelude Therapeutics Incorporated, which trades on the Nasdaq under the ticker PRLD. The company is the sponsor of the clinical studies evaluating the compound.

What phase is PRT1419 in?

PRT1419 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication.

What clinical trials is PRT1419 in?

PRT1419 has been evaluated in two completed Phase 1 trials: NCT04837677 in advanced solid tumors including sarcoma, and NCT04543305 in relapsed or refractory hematologic malignancies including multiple myeloma. Both studies were conducted in the United States.