New study seeks safer dosing of cancer drug for patients with liver issues
NCT ID NCT07036133
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the drug pralatrexate in 24 adults with advanced cancer and varying levels of liver function. The goal is to see how the body processes the drug and to find the right dose for people with mild, moderate, or severe liver impairment. Participants receive the drug weekly for six weeks, followed by a week off, while researchers monitor side effects and drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pralatrexate
- What this could lead to
- If successful, this study could help doctors safely dose pralatrexate in cancer patients with liver problems, expanding treatment options.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety and dosing, not on curing cancer. The drug may not work well or could cause side effects, especially in those with severe liver impairment.
Why investors are watching
Aurobindo Pharma Limited, through its subsidiary Acrotech Biopharma Inc., is running a phase 1 trial of the cancer drug pralatrexate in patients with different levels of liver function. The trial tests how the body processes the drug when the liver is impaired, which helps set safe dosing. For a small company, this readout matters because it could expand the drug's use to a broader patient group or reveal safety limits.
If it works: A positive result could support dosing guidance for patients with liver problems, potentially widening the drug's label and making it more useful to doctors. That could strengthen Acrotech's position in the oncology market.
If it fails: The trial could show that pralatrexate is unsafe or poorly tolerated in patients with liver impairment, which would limit its use in that group. Phase 1 trials often fail or take longer than expected, so a delay or negative finding would set back the company's plans.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gabrail Cancer Center
RECRUITINGCanton, Ohio, 44718, United States
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Karmanos Cancer Institute
RECRUITINGDetroit, Michigan, 48201, United States
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Northwestern University - Feinberg School of Medicine
RECRUITINGChicago, Illinois, 60611, United States
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TOI Clinical Research
WITHDRAWNCerritos, California, 90703, United States
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