Advanced Solid TumorsPhase 1SPI-FOL-102NCT07036133
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
A Phase 1 study testing Pralatrexate Injection in people with Advanced Solid Tumors and Hematologic Malignancies, run by Acrotech Biopharma Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Hematologic Malignancies
- What is being tested?
- Pralatrexate Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Dec 2022to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
Nashat Gabrail, MD
- Withdrawn
TOI Clinical Research
Cerritos, California, 90703
- Recruiting
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611
Devalingam Mahalingam, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Wasif Saif, MD
About this study
Official title: 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 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.
Read the detailed description
This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.
- Conditions
- Advanced Solid Tumors, Hematologic Malignancies
- Being tested
- Pralatrexate Injection
- Keywords
- Pralatrexate
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pralatrexate InjectionDrug
Pralatrexate will be administered based on Child-Pugh Classification of liver impairment
| Study group | Role | What they receive |
|---|---|---|
| Open-label treatment with Pralatrexate | Other | Pralatrexate will be administered based on Child-Pugh Classification of liver impairment. Receives: Drug: Pralatrexate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During week 1 of the first cycle of treatment (each cycle is 7 weeks).
Secondary outcomes (1)
To evaluate the safety of pralatrexate
The number and severity of treatment-related adverse events. This will be as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale, Version 5.0.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start28 Dec 2022
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erard Gilles, MD, MSc, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036133
- Sponsor's protocol ID
- FOL-102
- Acronym
- SPI-FOL-102
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07036133
- Acronym / sponsor ID
- SPI-FOL-102 / FOL-102
- Conditions
- Advanced Solid Tumors, Hematologic Malignancies
- Keywords
- Pralatrexate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label treatment with Pralatrexate | Other | Drug: Pralatrexate InjectionPralatrexate will be administered based on Child-Pugh Classification of liver impairment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pralatrexate InjectionPralatrexate will be administered based on Child-Pugh Classification of liver impairment | Drug | Open-label treatment with Pralatrexate |
Primary outcome
To evaluate the pharmacokinetic (PK) profile of pralatrexate.
Time frame: 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.
1 secondary outcome
To evaluate the safety of pralatrexate
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erard Gilles, MD, MSc study director
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pralatrexate Injection in people with Advanced Solid Tumors and Hematologic Malignancies, run by Acrotech Biopharma Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uma Srinivas Atmuri (732-917-2420, uatmuri@acrotechbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.