ClinicalTrials.gg
Not yet recruitingNCT07515924Updated Sep 23, 2026

Oral Gallium Maltolate for Recurrent Glioblastoma

An Early Phase 1 interventional study of Gallium Maltolate and Surgical Intervention in Glioblastoma, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Medical College of Wisconsin · Early Phase 1, Interventional, and Treatment

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Phase
Early Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,301 studies in Glioblastoma with a site in United States — 194 open to participants now, 325 under way, 15 of them phase 3. Glioblastoma · United States.

Planned enrollment
1,000th of 1,154
8 · median 33
Started
2027
with 8 others
Phase 1
481 of 1,301
71 open now
Primary completion
2028-03
later than 224 of 323 live
Registered
1,270th of 1,301
by date

Among the 1,301 studies in Glioblastoma with a site in United States, this one is the 1,000th largest by planned enrollment of the 1,154 interventional ones that give a count, is one of 9 that started in 2027, is one of 481 in phase 1, reaches primary completion later than 224 of the 323 other live ones, and was the 1,270th registered.

Glioblastoma

2,134 studies on the registry are indexed under Glioblastoma; 466 are open to participants now.

Browse Glioblastoma studies →

Open to participants now

194 of the 1,301 studies in Glioblastoma with a site in United States are open now. Recruiting first, the newest first:

189 more — sign in →

All 194 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This is a Phase 0 investigational study to assess the central nervous system penetration and tumoral concentration of gallium in patients with recurrent glioblastoma administered with preoperative gallium maltolate.

Read the detailed description

Rationale: Currently, recruitment has concluded for a Phase 1 trial assessing in patients with GBM. Preliminary analyses have demonstrated gallium maltolate is both safe and potentially efficacious in treating glioblastoma. However, while gallium maltolate has been well-tolerated, further correlative analyses are necessary to confirm the drug's ability to act within the brain.

03

Conditions studied

  • Glioblastoma

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Keywords

  • glioblastoma
  • Gallium Maltolate
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age >18 years
  2. Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  3. All subjects must have a prior histological diagnosis of Glioblastoma (GBM) (WHO grade IV) or molecular features of GBM (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
  4. Subjects are required to have received standard treatment which consists of radiotherapy and temozolomide (i.e., the Stupp Protocol). Treatment with adjuvant temozolomide must be completed at least four weeks prior to GaM administration to avoid potential for overlapping toxicity with GaM. Although the half-life (T½) of temozolomide is 1.8 hours and it would be expected to be cleared by five half-lives, some patients receiving temozolomide may experience a delayed suppression of their (ANC). Hence, a four-week interval between completion of temozolomide and GaM will be required. There is no maximum limit to the amount of chemotherapy or radiation patients have received prior to enrollment.
  5. Subjects must be symptomatically stable, without new or rapidly worsening neurologic deficits for a minimum of 14 days prior to screening.
  6. Subjects must have been reviewed by a multidisciplinary group comprised of Central Nervous System oncology experts (which could include neuro-oncology, radiation oncology, neurosurgery, and radiology) to have radiographic signs of tumor progression (as defined by the RANO criteria) requiring surgical pathologic specimen (stereotactic or craniotomy for debulking/resection).
  7. (ECOG) performance status of 0-2.
  8. Subjects must have adequate bone marrow function as evidenced by:

    1. an ANC of >1500/μL (stable off any growth factor within one week of study drug administration)
    2. > 9 g/dL
    3. count > 100,000/μL without transfusion within one week
  9. Subjects must have adequate hepatic and renal function based on the following laboratory tests:

    1. (ALT) ≤ 2 x (ULN)
    2. Aspartate aminotransferase (AST) ≤ 2 x ULN
    3. Alkaline phosphatase ≤ 2 x ULN
    4. Total ≤ 2 x ULN
    5. Creatinine \< 1.5 mg/dL or (GFR) by modification of diet in renal disease (MDRD) > 45
  10. Female subjects must meet one of the following:

    1. for at least one year before enrollment, OR
    2. Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR
    3. If subject is of (defined as not satisfying either of the above two criteria), agree to practice two acceptable methods of (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the form through 21 days after the last dose of study agent, OR
    4. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.)
  11. Male subjects, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:

    1. Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
    2. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  12. Subjects taking oral iron supplements or iron chelators must discontinue these medications at least one week prior to starting GaM since these agents may impact on the efficacy of GaM. Drug-drug interactions between GaM and other concomitant medications have not been reported.

Exclusion criteria

Exclusion Criteria:

  1. Presence of other active malignant disease diagnosed within 12 months, with the exception of adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less , or cervical intraepithelial neoplasia. Active is malignancy receiving treatment.
  2. Prior chemotherapy or radiotherapy within 14 days of study entry.
  3. Known to or intolerance to gallium-based medications.
  4. Concurrent use of cytotoxic chemotherapy is not permitted.
  5. Unstable or severe concurrent medical conditions such as severe heart ( Class 3 or 4) or known lung (forced expiratory volume (FEV) \<50%) disease, uncontrolled diabetes mellitus.
  6. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.
  7. Subjects who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
  8. Subjects with new or worsening neurologic deficits that would require surgical treatment before complete administration of the study drug.
  9. Inability to tolerate an oral medication or keep pills down.
  10. Subjects who are pregnant or nursing.
  11. Subjects with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Gallium Maltolate

    Gallium Maltolate will be administered on an outpatient basis. Subjects will take it for 14 days prior to surgical intervention.

    Drug: Gallium Maltolate · Procedure: Surgical Intervention

Interventions

  • Gallium Maltolate will be administered at a total daily dose of 2500 mg.

    Also known as: CAS 108560-70-9

  • ProcedureSurgical Intervention

    Patients will be scheduled for surgical intervention (needle biopsy or resection) as deemed necessary by the clinical team after 14 ± 5 days of oral Gallium Maltolate administration.

06

What researchers measure

Primary outcomes

  1. Glioma Tissue Difference

    The difference in gallium concentration between glioma tissue resected from patients treated with gallium maltolate and matched glioma tissue from untreated patients from a tumor bank registry, matched based on age, pathology, and gender. The measure type will be mean reported with standard deviation.

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2027; primary completion for Mar 2028, 12 months later.

Of 240 non-industry phase 1 interventional studies under Glioblastoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 76. This study's planned 12 months is below that.

Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2026
First posted
Apr 7, 2026
StartEst.
Mar 2027
Primary completionEst.
Mar 2028
CompletionEst.
Mar 2028
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07515924
Responsible party
Rupen Desai, MD (Assistant Professor, Medical College of Wisconsin) — Principal investigator
First posted
Apr 7, 2026
Start date
Mar 2027 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office
Contact
cccto@mcw.edu
866-680-0505 ext. 8900
Rupen Desai, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Gallium maltolate

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