Pralatrexate dosing and safety in adults with cancer and differing liver function

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 trial will test how pralatrexate is processed by the body and what doses are safe for adults with advanced solid tumors or blood cancers who have normal or impaired liver function.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Acrotech Biopharma Inc. (industry)
• Locations: 4 sites (Cerritos, California and 3 other locations)
• Trial ID: NCT07036133 on ClinicalTrials.gov

What this trial studies

This open‑label, non-randomized Phase 1 study enrolls adults with advanced solid tumors or hematologic malignancies and groups them by liver function (normal, mild, moderate, or severe hepatic impairment by Child‑Pugh). Participants receive pralatrexate once weekly for 6 weeks of a 7‑week treatment cycle while intensive pharmacokinetic blood sampling and safety monitoring are performed. The study compares drug levels and adverse events across liver‑function groups to recommend appropriate dosing adjustments. Results will inform dosing guidance for pralatrexate in patients with varying degrees of hepatic impairment.

Who should consider this trial

Good fit: Adults (≥18 years) with advanced solid tumors or hematologic malignancies who have normal or Child‑Pugh A–C hepatic function, adequate blood counts and renal function, ECOG ≤2, and a life expectancy of at least 6 months.

Not a fit: Patients with poor performance status (ECOG >2), inadequate hematologic or renal function, life expectancy under 6 months, or inability to comply with frequent visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could provide safer, evidence‑based pralatrexate dosing recommendations for patients with liver impairment, lowering toxicity risk and allowing appropriate treatment.

How similar studies have performed: Pharmacokinetic and dose‑adjustment studies for chemotherapy agents, including antifolates, have successfully guided dosing in hepatic impairment, but pralatrexate‑specific hepatic PK data remain limited so this application is partly novel.

Eligibility criteria

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.

Where this trial is running

Cerritos, California and 3 other locations

• TOI Clinical Research — Cerritos, California, United States (WITHDRAWN)
• Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States (RECRUITING)
• Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
• Gabrail Cancer Center — Canton, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Uma Srinivas Atmuri

Conditions: Advanced Solid Tumors, Hematologic Malignancies, Pralatrexate