CompletedPhase 1

A Study of PRT2527 in Participants With Advanced Solid Tumors

United States30 participantsStarted 2022-02-14

Plain-language summary

This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Selected sarcomas with a documented gene fusion
✓. Castrate resistant prostate cancer (CRPC)
✓. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer
✓. Non-small cell lung cancer (NSCLC)
✓. MYC amplified solid tumors

Exclusion criteria

✕. Curatively treated malignancy with no known active disease
✕. Curatively treated non-melanoma skin cancer without evidence of disease
✕. Curatively treated carcinoma in situ without evidence of disease

What they're measuring

Dose limiting toxicities (DLT) of PRT2527

Timeframe: Baseline through Day 21

Maximally tolerated dose (MTD) of PRT2527

Timeframe: Baseline through approximately 1 year

Recommended phase 2 dose (RP2D) and schedule of PRT2527

Timeframe: Baseline through approximately 1 year

Trial details

NCT IDNCT05159518

SponsorPrelude Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-06

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