Trials / Completed

CompletedNCT05159518

A Study of PRT2527 in Participants With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose Escalation and Confirmation Study of PRT2527 in Participants With Advanced Solid Tumors

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 30 (actual)

Sponsor: Prelude Therapeutics · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open-label, dose-escalation and confirmation Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating participants with selected advanced/metastatic sarcomas displaying a documented gene fusion, castrate resistant prostate cancer, hormone receptor positive HER2-negative breast cancer, advanced/metastatic non-small cell lung cancer, and solid tumors displaying MYC amplification. The study plan expects to evaluate approximately six dose levels of approximately 1-6 participants per dose level; however additional and/or intermediate dose levels may be explored. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. The total sample size will be approximately 30 patients for MTD and RP2D determination.

Conditions

Interventions

Type	Name	Description
DRUG	PRT2527	PRT2527 will be administered by intravenous infusion

Timeline

Start date: 2022-02-14
Primary completion: 2023-12-06
Completion: 2023-12-06
First posted: 2021-12-16
Last updated: 2023-12-11

Locations

8 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05159518. Inclusion in this directory is not an endorsement.