Clinical Trials Directory

Trials / Completed

CompletedNCT03886831

A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
232 (actual)
Sponsor
Prelude Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT543.

Detailed description

This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). The study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion part involving up to ten separate cohorts. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT543.

Conditions

Interventions

TypeNameDescription
DRUGPRT543PRT543 will be administered orally

Timeline

Start date
2019-02-11
Primary completion
2022-11-16
Completion
2022-11-16
First posted
2019-03-22
Last updated
2023-03-28

Locations

23 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03886831. Inclusion in this directory is not an endorsement.