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

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.

NCT Number	NCT07036133
Lead Sponsor	Acrotech Biopharma Inc.
Conditions	Advanced Solid Tumors, Hematologic Malignancies
Enrollment	24 participants
Start Date	2022-12-28
Primary Completion	2027-02 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-02-11