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GliomaPhase 1NCT07541781

Sitagliptin in Recurrent/Progressive Grade 4 Glioma

A Phase 1 study testing Sitagliptin and Bevacizumab in people with Glioma and Glioblastoma, run by Kailin Yang, MD, PhD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma, Glioblastoma, Recurrent Glioma
What is being tested?
Sitagliptin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
11 Jun 2026to 11 Jun 2030
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

  • Phase 1b
  • Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
  • Subjects must not have received sitagliptin or bevacizumab for this disease.
  • Age >18 years
  • Performance status: ECOG performance status 0-2
  • Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
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  • Hemoglobin ≥ 9 g/dl
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
  • AST (SGOT) ≤ 3 X institutional ULN
  • ALT (SGPT) ≤ 3 X institutional ULN
  • Calculated creatinine clearance > 50 mL/min
  • Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio.
  • For UPC ratio > 0.5, 24-hour urine protein must be obtained and must be < 1000 mg.
  • Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days prior to treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.
  • Subjects must be able to swallow whole tablets.
  • Participants must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy
  • Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study treatment
  • Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1 Day 1:
  • surgery - 4 weeks
  • nitrosoureas - 6 weeks
  • cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.
  • For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.
  • Investigational therapy or non-cytotoxic GBM related therapy - 2 weeks
  • Subject is not deemed as a surgical candidate.
  • Pilot Phase
  • Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
  • Subjects must not have received sitagliptin or bevacizumab for this disease.
  • Age >18 years
  • Performance status: ECOG performance status 0-2
  • Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
  • Hemoglobin ≥ 9 g/dl
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
  • AST (SGOT) ≤ 3 X institutional ULN Version date: 30March2026 Page 16
  • ALT (SGPT) ≤ 3 X institutional ULN
  • Calculated creatinine clearance > 50 mL/min
  • Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio.
  • For UPC ratio > 0.5, 24-hour urine protein must be obtained and must be < 1000 mg.
  • Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days of treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.
  • Subjects must be able to swallow whole tablets.
  • Subjects must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy
  • Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to treatment start
  • Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1Day1:
  • surgery - 4 weeks
  • nitrosoureas - 6 weeks
  • cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.
  • For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.
  • Investigational therapy or GBM related non-cytotoxic therapy - 2 weeks
  • For bevacizumab (if for a different cancer) - 4 weeks from the expected date of protocol surgery
  • Subject is deemed as a surgical candidate.

Who cannot join

  • Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except for alopecia and neuropathy.
  • Subjects receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin or bevacizumab.
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sitagliptin and/or bevacizumab. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy.
  • Other malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or vulva; c) prostate cancer of Gleason Score 6 or less with stable prostate specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreas.
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  • Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v.5.0] diarrhea of any etiology at screening).
  • Known active infection with hepatitis B or hepatitis C virus.
  • Pregnant or breastfeeding.
  • Subjects who receive insulin or sulfonylurea for diabetes mellitus.
  • Subjects with history of type 1 diabetes, uncontrolled type 2 diabetes, hypoglycemia requiring medical intervention, or those who are deemed not suitable to receive sitagliptin at the discretion of the investigators.
  • Unable or unwilling to swallow tablets.
  • Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator's judgment, make the patient inappropriate for this study.
  • Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study consent.
  • Subjects with history of hematologic bleeding disorder.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kailin Yang, MD, PhD contact

+1 319 356 3630

kailin-yang@uiowa.edu

United States1 site, 1 recruiting
  • University of Iowa Health Care

    Iowa City, Iowa, 52242

    Kailin Yang, MD, PhD, +1 319 356 3630, kailin-yang@uiowa.edu

    Kailin Yang, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Targeting Myeloid-Derived Suppressor Cells in Patients With Recurrent/Progressive Grade 4 Glioma: Phase 1 Trial of Sitagliptin

Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab.

Read the detailed description

In this Phase I trial, it is proposed that sitagliptin will be used to inhibit Myeloid Derived Suppressor Cells (MDSCs) in recurrent Glioblastoma (GBM). As this trial designed is for patients with recurrent GBM, patients will receive standard of care, bevacizumab, in addition to sitagliptin. The goal of this trial is to provide the proof of concept that suppressing MDSCs via sitagliptin is safe and feasible in patients with recurrent GBMs.

In the Phase Ib component, a standard 3+3 design and dose de-escalation will be used to determine the maximal tolerated dose (MTD) of sitagliptin in combination with bevacizumab in non-surgical patients with recurrent GBM.

After completion of the Phase Ib part, the study will proceed to the pilot phase. In the pilot phase component, 12 patients with recurrent GBM, who will receive pre-operative treatment with sitagliptin for at least 5 days at the MTD determined in phase 1b, will be enrolled. These patients will then undergo surgical resection of the tumor. All patients will receive postoperative sitagliptin in addition to standard-of-care bevacizumab. Tumor tissue will undergo dissociation and single-cell sequencing, immune profiling, and whole genome sequencing. The goal of the pilot phase is to obtain preliminary evidence demonstrating a reduction in the concentration of circulating MDSCs after the treatment of sitagliptin and to provide preliminary evidence of sitagliptin in reducing infiltrating MDSCs in the GBM tumor microenvironment. Patients will have their steroid dosing reduced to the equivalence of 4 mg dexamethasone per day or lower for at least 5 days prior to preoperative sitagliptin.

Medical subject headings
Glioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitagliptinDrug

    Sitagliptin, PO dose to be determined by Phase I dose de-escalation, cycle length 28 days. Treatment until progression.

  • BevacizumabBiological

    Also called Avastin

    Bevacizumab, IV, 10 mg/kg days 1 and 15 every 28 days, until progression.

Study groups in NCT07541781
Study groupRoleWhat they receive
Standard of care Bevacizumab in addition to SitagliptinExperimentalPhase I: Bevacizumab in combination with Sitagliptin Phase Ib: a standard 3+3 design and dose de-escalation will be used to determine the maximal tolerated dose (MTD) of sitagliptin in combination with bevacizumab on non-surgical patients with recurrent GBM Pilot: 12 patients with recurrent GBM, will receive pre-operative treatment with sitagliptin for at least 5 days at the MTD determined in phase 1b. These patients will then undergo surgical resection of the tumor. All patients will receive postoperative sitagliptin in addition to standard-of-care bevacizumab
Receives: Drug: Sitagliptin; Biological: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Dose-limiting toxicities as measured by CTCAE v5.0

    A dose limiting toxicity (DLT) is defined as any of the following sitagliptin-related adverse event (AE) that occurs during the DLT period (first day of treatment through completion of cycle 2 of therapy; each cycle is 28 days), graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: First day of treatment through completion of cycle 2 of therapy (each cycle is 28 days)

  2. Pilot: Change in participants' concentration of circulating MDSCs with treatment

    A two-sided p-value for a test of the null hypothesis, that the ΔPost-Pre in MDSCs is equal to 0 versus the alternative, that it is not equal to 0, will be computed using a one-sample test. In addition, the mean and two-sided 95% confidence interval will be reported.

    Measured: From pre- to post-treatment (end of post-op cycle 1; each cycle is 28 days).

Secondary outcomes (2)
  1. Event-free survival (EFS)

    Time from study treatment initiation to progression which precludes surgery, recurrence or death due to any cause

    Measured: From study treatment initiation through three years

  2. Overall survival (OS)

    Time from study treatment initiation to death due to any cause

    Measured: From study treatment initiation through three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start11 Jun 2026
  3. Primary completion11 Jun 2029 (estimated)
  4. Study completion11 Jun 2030 (estimated)

Resources

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07541781
Sponsor's protocol ID
202512310
Status last verified
Jun 2026
First submitted
10 Apr 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sitagliptin and Bevacizumab in people with Glioma and Glioblastoma, run by Kailin Yang, MD, PhD at 1 site 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 61 inclusion and 15 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Kailin Yang, MD, PhD (+1 319 356 3630, kailin-yang@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Dose-limiting toxicities as measured by CTCAE v5.0 (time frame: First day of treatment through completion of cycle 2 of therapy (each cycle is 28 days)). The study lists 2 primary outcomes in all. 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 17 Jun 2026.

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