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PRT811

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Apr 5, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

PRT811 · 1 trial · 2 indications

Phase 1 1
NCT04089449A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and GliomasAdvanced Solid Tumor
COMPLETED86 Analytics
PHASE1COMPLETED
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

To describe dose limiting toxicities (DLT) of PRT811
Baseline through Day 21

Dose limiting toxicities will be evaluated through the first cycle

To determine the maximally tolerated dose (MTD)
Baseline through approximately 2 years

The MTD will be established for further investigation in participants with solid tumors and gliomas

To determine the recommended phase 2 dose (RP2D) and schedule of PRT811
Baseline through approximately 2 years

The RP2D will be established for further investigation in participants with solid tumors and gliomas

Secondary Endpoints

To describe the adverse event profile and tolerability of PRT811
Baseline through approximately 2 years
To describe the pharmacokinetic profile of PRT811
Cycle 1 (each cycle is 21 days) on Days 1, 8 and 14. For subsequent cycles, Day 1 of each cycle through the end of study treatment, an average of 6 months
To describe any anti-tumor activity of PRT811
Baseline through approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PRT811EXPERIMENTALPRT811 will be administered orally

Interventions

NameTypeDescription
PRT811DRUGPRT811 will be administered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies * Subjects must have recovered from the effects of any prio...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about PRT811

What is PRT811 used for?

PRT811 is an investigational small molecule being studied for the treatment of advanced solid tumors, including recurrent glioma. It is also being evaluated in central nervous system lymphoma. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who is developing PRT811?

PRT811 is being developed by Prelude Therapeutics Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol PRLD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational oncology drug.

What phase is PRT811 in?

PRT811 is in Phase 1 clinical development. A Phase 1 study of PRT811 in participants with advanced solid tumors, CNS lymphoma, and gliomas has been completed. The drug remains investigational and has not received regulatory approval.

What clinical trials has PRT811 been in?

PRT811 has been studied in a Phase 1 clinical trial identified as NCT04089449, titled "A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas." This trial enrolled 86 participants in the United States and has been completed.

Is PRT811 the same as any other drug?

PRT811 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a distinct small molecule being developed by Prelude Therapeutics for oncology indications.