NCT07036133

Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment

A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment. Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.

Detailed description

This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.

Conditions

• Advanced Solid Tumors
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Pralatrexate Injection	Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

Timeline

• Start date: 2022-12-28
• Primary completion: 2027-02-01
• Completion: 2027-09-01
• First posted: 2025-06-25
• Last updated: 2026-02-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study