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Pralatrexate for Advanced Solid Tumors or Blood Cancers with Liver Impairment

This study is looking at how your body handles a medicine called pralatrexate, which is used to treat advanced solid tumors or blood cancers. Researchers want to understand how pralatrexate is absorbed, broken down, and removed (this is called pharmacokinetics or PK) in people with different levels of liver function. They also want to check the safety of pralatrexate and figure out the best dose for people with liver problems. You might be able to join if you are at least 18 years old, have an advanced solid tumor or blood cancer, and have a life expectancy of at least 6 months. The study aims to see how pralatrexate works in your body during the first week of treatment.

Study design
This is an open-label, multi-center study that is not randomized. It plans to include 24 participants.
What's involved
You would need to be willing to give written informed consent and follow the dosing and visit schedules, as well as all study requirements. Pralatrexate will be given once weekly for 6 weeks of every 7-week treatment cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during week 1 of the first cycle of treatment (each cycle is 7 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Acrotech Biopharma Inc.
~24 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Pralatrexate Injection

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the pharmacokinetic (PK) profile of pralatrexate.
Measured over During week 1 of the first cycle of treatment (each cycle is 7 weeks).

Conditions

Advanced Solid Tumors
Hematologic Malignancies

Explore related trials

Hematologic NeoplasmSolid Neoplasm

Where it's being run

4 sites across 4 states
California1
Illinois1
Michigan1
Ohio1

Study leadership

  • Erard Gilles, MD, MSc · STUDY_DIRECTOR

Who to contact

Uma Srinivas Atmuri
[email protected]
732-917-2420
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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.

What this trial measures

  • To evaluate the pharmacokinetic (PK) profile of pralatrexate.During week 1 of the first cycle of treatment (each cycle is 7 weeks).

    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.