NCT04837677

A Study of PRT1419 in Patients With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Prelude Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

Detailed description

This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients with relapsed or refractory solid tumors, including breast, lung, sarcoma and melanoma as part of a 28-day treatment cycle. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.

Conditions

• Sarcoma
• Melanoma
• Lung Cancer
• Breast Cancer
• Esophageal Cancer
• Cervical Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	PRT1419	PRT1419 will be administered by intravenous infusion

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2021-04-08
• Last updated: 2023-03-15

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study