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 (SPI-FOL-102)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors; Hematologic Malignancies
• Intervention / Treatment: Drug: Pralatrexate Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Uma Srinivas Atmuri; Phone Number: 732-917-2420; Email: uatmuri@acrotechbiopharma.com
• Study Contact Backup: Name: Motun Clinical Trial Manager; Phone Number: 617-694-4296; Email: msolomon@acrotechbiopharma.com

Study Locations

• United States
  • California
    • Cerritos, California, United States, 90703
      • Withdrawn
      • TOI Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University - Feinberg School of Medicine
      • Principal Investigator: Devalingam Mahalingam, MD
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Principal Investigator: Wasif Saif, MD
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center
      • Principal Investigator: Nashat Gabrail, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
• Patient is diagnosed with advanced solid tumor or hematological malignancy.
• Patient is at least 18 years of age and has a life expectancy of at least 6 months.
• Patient has normal or abnormal hepatic function as defined by normal, mild (Child-Pugh A), moderate (Child-Pugh B ), or severe (Child-Pugh C) liver impairment
• Patient has adequate hematologic and renal function as defined by:

Absolute neutrophil count (ANC) ≥1000/μL Platelet count ≥100,000/μL Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥50 mL/min

• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of pralatrexate
• Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or who are surgically sterilized do not require this test.

Exclusion Criteria:

• Patient has had previous exposure to pralatrexate
• Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
• Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive the protocol-defined treatment.
• Patient has known or suspected intolerance or hypersensitivity to the investigational product or any related compound.
• Patient has congestive heart failure at Class III/IV according to the New York Heart Association (NYHA) Functional Classification
• Patient has had major surgery within 30 days prior to enrollment.
• Patient with central nervous system (CNS) metastases
• Patient is pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open-label treatment with Pralatrexate; Pralatrexate will be administered based on Child-Pugh Classification of liver impairment.	Drug: Pralatrexate Injection; Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the pharmacokinetic (PK) profile of pralatrexate.	Blood will be collected to evaluate the pharmacokinetic (PK) profile of pralatrexate (plasma concentration levels) when administered to patients with various degrees of hepatic impairment.	During week 1 of the first cycle of treatment (each cycle is 7 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of pralatrexate	The number and severity of treatment-related adverse events. This will be as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale, Version 5.0.	This will be evaluated during the study through 14(±3) days after the last dose in Cycle 1, or 35(±5) days after the final dose in any cycle or until all treatment-related AEs have resolved or returned to Baseline/Grade

Collaborators and Investigators

• Sponsor: Acrotech Biopharma Inc.
• Investigators: Study Director: Erard Gilles, MD, MSc

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: June 16, 2025
• First Posted (Actual): June 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pralatrexate
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; 10-propargyl-10-deazaaminopterin
• Other Study ID Numbers: FOL-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No