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

NCT07036133 | Recruiting Phase 1 FDA Drug

• 1 other identifier: FOL-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hematologic Malignancies; Advanced Solid Tumors

Keywords

Pralatrexate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the safety of pralatrexate

  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

Study Arms (1)

Open-label treatment with Pralatrexate

OTHER

Pralatrexate will be administered based on Child-Pugh Classification of liver impairment.

Drug: Pralatrexate Injection

Interventions

Pralatrexate Injection DRUG

Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

Open-label treatment with Pralatrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead

Study Sites (4)

TOI Clinical Research

Cerritos, California, 90703, United States

WITHDRAWN

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Gabrail Cancer Center

Canton, Ohio, 44718, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Erard Gilles, MD, MSc

  STUDY DIRECTOR

Central Study Contacts

Uma Srinivas Atmuri

CONTACT

732-917-2420; uatmuri@acrotechbiopharma.com

Motun Clinical Trial Manager

CONTACT

617-694-4296; msolomon@acrotechbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: June 25, 2025
• Study Start: December 28, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)