Recruiting
Phase 1

Pralatrexate

Sponsor:

Acrotech Biopharma Inc.

Code:

NCT07036133

Conditions

Advanced Solid Tumors

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pralatrexate Injection

Study Details

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

Advanced Solid Tumors

Hematologic Malignancies

Study ID

NCT07036133

Start date

Dec 28, 2022

Status verified date

Feb, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Open-label treatment with Pralatrexate

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

Interventions

Pralatrexate Injection

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Uma Srinivas Atmuri

732-917-2420uatmuri@acrotechbiopharma.com

Motun Clinical Trial Manager

617-694-4296msolomon@acrotechbiopharma.com

Locations

Northwestern University - Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Devalingam Mahalingam, MD

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Wasif Saif, MD

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Principal Investigator:

Nashat Gabrail, MD

More Information

Sponsor

Acrotech Biopharma Inc.

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Pralatrexate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Acrotech Biopharma Inc. on 2026-02-11.