GliomaPhase 2NCT03050736
Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression
A Phase 2 study testing VAL-083 (Dianhydrogalactitol) in people with Glioma and Glioblastoma, run by Kintara Therapeutics, Inc. at 1 site in China.
Trial summary
The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT)… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Glioma, Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- VAL-083 (Dianhydrogalactitol)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2017to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed histologically proven supratentorial GBM
- Tumor tissue specimens from the GBM surgery or open biopsy must be available for MGMT gene promoter status analysis and central pathology review.
- Documented unmethylated MGMT gene promoter status
- Males or females ≥18< 70 years of age.
- Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
- Cranial MRI must have been performed within 21 days of study entry and MRI must be used throughout the period of protocol treatment for tumor measurement. If the surgical procedure was a resection, cranial MRI performed within 72 hours of resection is preferred
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- Stable or decreasing dose of steroids for ≥5 days prior to randomization.
- Karnofsky performance score ≥ 70%
- Patients must begin treatment with VAL-083 chemotherapy no sooner than 2 weeks and no later than 4 weeks from the diagnostic surgery.
- ANC ≥1,500/ µl
- Platelet count ≥ 100,000/µl
- Hemoglobin ≥ 10 gm/dl
- AST, ALT < 2.5 times ULN
- Bilirubin < 2.5 ULN
- Serum creatinine ≤ 1.5x ULN or creatinine clearance > 50 mL/min (measured or calculated by the Cockcroft-Gault formula) (Cockcroft, 1976) at screening
Who cannot join
- Prior chemotherapy within the last 5 years.
- Prior radiation therapy of the head.
- Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of VAL-083.
- Prior systemic anti-angiogenic therapy.
- Placement of Gliadel® wafer at surgery.
- Planned surgery for other diseases (e.g. dental extraction).
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- History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
- History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥5 years are eligible for this study.
- History of coagulation disorder associated with bleeding or recurrent thrombotic events.
- Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III, IV) or history of myocardial infarction during the past 6 months; or uncontrolled arterial hypertension.
- Inability to undergo Gd-MRI.
- Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
- Subject is pregnant (positive serum beta human chorionic gonadotropin [b-HCG] test at screening) or is currently breast-feeding, anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
- Current alcohol dependence or drug abuse.
- Known hypersensitivity to the study treatment.
- Legal incapacity or limited legal capacity.
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Trial of Dianhydrogalactitol (VAL-083) and Radiation Therapy in Treatment of Newly Diagnosed GBM Patients With An Unmethylated Promoter of the Methylguanine-DNA Methyltransferase (MGMT) Gene
The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
Read the detailed description
Malignant gliomas are the most common primary central nervous system tumors found in adults, with WHO Grade IV malignant glioma (GBM) representing the most aggressive and prevalent sub-type of these tumors having one of the worst 5-year survival rates among all human cancers.
Standard therapy for patients with malignant gliomas has traditionally involved maximal surgical resection/debulking of the primary tumor (if feasible), followed by adjuvant radiotherapy over 6-8 weeks, with or without chemotherapy. The oral alkylating agent temozolomide was found to increase median survival when used in combination with radiotherapy, compared to radiotherapy alone, in patients with newly diagnosed GBM. However, expression of O6-methylguanine methyltransferase (MGMT) in GBM has been linked to poor patient outcome in patients treated with temozolomide.
The study drug, dianhydrogalactitol (VAL 083) is a bi-functional N7 DNA alkylating agent which has demonstrated cytotoxic activity that is independent of chemo-resistance due to expression of MGMT. This makes VAL-083 an ideal candidate to treat patients who are unlikely to respond to temozolomide due to MGMT expression in their GBM. Furthermore, VAL-083 acted as a radio-sensitizer at low (1 - 2.5μM) concentrations in all GBM cultures tested.
VAL-083 has been studied extensively in the United States by the National Cancer Institute. The NCI studies suggested that VAL-083 appeared to have activity in some types of cancer (lung and brain), including GBM; however, further VAL-083 research was not pursued in the US due to an increased focus on targeted biologic therapies during that era. VAL-083 has also been studied in the People's Republic of China, where it is currently approved and marketed for treatment of chronic myeloid leukemia and lung cancer. At present, VAL-083 is being studied in clinical trials in the United States as a third-line treatment option for patients with recurrent GBM following failure of surgery, radiation therapy, temozolomide and bevacizumab. Interim results support safety of VAL-083 in this population; to date, a regimen of 40mg/m2/d x 3 days IV in a 21 day cycle has been confirmed to be safe and well tolerated.
This phase 2, open-label, single arm study will be conducted in a dose-escalation cohort scheme to confirm the optimal dose of VAL-083, when administered concurrently with radiation therapy. Dose escalation will proceed in three sequential cohorts, consisting of patients receiving VAL-083 at 20, 30 and 40 mg/m2/d x 3 every 21 days.
This trial will be conducted in 2 parts. Part 1 will consist of 1) a 42-day induction period, during which patients will receive VAL-083 while undergoing radiation treatment at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks (for a total dose of 60 Gy), followed by 2) adjuvant maintenance therapy with VAL-083 alone, administered daily x 3 IV every 3 weeks at the same assigned dose, for a maximum of 8 maintenance cycles. Part 2 will comprise an expansion phase, in which VAL-083 will be studied in up to 20 additional subjects. The dose of VAL-083 that will be studied in Part 2 will be determined from Part 1.
Patients will undergo safety assessments including physical examinations, vital signs, hematology, serum chemistry, and urinalysis.
In both parts of the study, a pharmacokinetic study may be conducted at treatment Cycle 1 Day 1, in consenting patients. For patients consenting to CSF collection by lumbar puncture, a CSF sample will be obtained after completion of the Cycle 1, Day 3 VAL-083 infusion. These patients will also have a blood sample taken for VAL-083 plasma level after completion of drug infusion.
Response parameters will be evaluated according to the Response Assessment in NeuroOncology (RANO).
- Conditions
- Glioma, Glioblastoma, Glioblastoma Multiforme, GBM, Brain Cancer
- Being tested
- VAL-083 (Dianhydrogalactitol)
- Keywords
- Glioma, Glioblastoma, Glioblastoma multiforme, GBM, brain tumor, brain cancer
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAL-083 (Dianhydrogalactitol)Drug
VAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.
| Study group | Role | What they receive |
|---|---|---|
| VAL-083 (Dianhydrogalactitol) | Experimental | VAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts. Receives: Drug: VAL-083 (Dianhydrogalactitol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation of tumor response in patients, as measured by magnetic resonance imaging
Tumor response assessment via MRI, as long as patient continues to demonstrate response or stable disease and tolerates therapy.
Measured: Every 42 days while receiving radiotherapy then every 63 days while remaining on study, from patient randomization until study discontinuation for up to 10 months
Secondary outcomes (12)
Safety evaluation of VAL-083 in combination with a standard radiation therapy, as determined by incidence of patient adverse events and changes in laboratory results, ECG and vital signs
To confirm the safety and tolerability of VAL-083 in combination with a standard of care radiation regimen. Safety will be assessed through summaries of AEs, changes in laboratory test results, ECGs, and changes in vital signs for all patients who receive any amount of VAL-083.
Measured: Every 30 days, from patient randomization through 28 days following last study treatment for up to 10 months
Ctrough
Pre-dose plasma concentration of VAL-083
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Cmax
Maximum observed plasma concentration of VAL-083
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Tmax
Time of observed Cmax for VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
AUClast
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration of VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
AUCinf
Area under the concentration-time curve extrapolated to infinity for VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
CL/F
Total oral body clearance at steady state for VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Mean Residence Time
AUMC/AUC for VAL-083 in plasma, where AUMC is Area under the Moment Curve
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Vz
Volume of distribution during the terminal phase of VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Lambda z
Terminal elimination rate constant determined by selection of at least three decreasing data points on the terminal phase of the concentration-time curve for VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
T½
Terminal elimination half-life of VAL-083 in plasma
Measured: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Pharmacokinetic profile and dose-exposure relationship of VAL-083 in Cerebral Spinal Fluid (CSF)
VAL-083 levels in CSF will be correlated with VAL-083 levels in plasma drawn at Cycle 1 Day 3.
Measured: Once after completion of Cycle 1 Day 3 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start17 Dec 2017
- Primary completion22 Nov 2021
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Chen Zhong-ping, M.D., Ph.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050736
- Sponsor's protocol ID
- DLM-14-001
- Status last verified
- Aug 2025
- First submitted
- 27 Jan 2017
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Clinical Study Report for this trial will be prepared and provided to U.S. F.D.A. as required by applicable regulatory requirement(s). The trial investigator will be provided a copy of their patient data captured in the electronic data base for this trial.
Publications
Guo C, Yang Q, Deng M, Qiu X, Wu S, Du X, Sai K, Dai Z, Chen Z, Zhang J, Lin F, Ke C, Xi S, Hu W, Zhou Z, Li J, Cao X, Liao Y, Lv Y, Brown D, Langlands J, Johnson G, Bacha J, Kwan C, Kanekal S, Schwartz R, Chen Z. VAL-083 is effective in patients with newly-diagnosed MGMT-unmethylated glioblastoma: report of phase II study. Discov Oncol. 2025 Dec 12;17(1):104. doi: 10.1007/s12672-025-04235-y.
PubMed 41385182
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of Dianhydrogalactitol (VAL-083) and Radiation Therapy in Treatment of Newly Diagnosed GBM Patients With An Unmethylated Promoter of the Methylguanine-DNA Methyltransferase (MGMT) Gene
- ClinicalTrials.gov ID
- NCT03050736
- Acronym / sponsor ID
- DLM-14-001
- Conditions
- Glioma, Glioblastoma, Glioblastoma Multiforme, GBM, Brain Cancer
- Keywords
- Glioma, Glioblastoma, Glioblastoma multiforme, GBM, brain tumor, brain cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kintara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Feb 2017 (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.
The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
Detailed description
Malignant gliomas are the most common primary central nervous system tumors found in adults, with WHO Grade IV malignant glioma (GBM) representing the most aggressive and prevalent sub-type of these tumors having one of the worst 5-year survival rates among all human cancers.
Standard therapy for patients with malignant gliomas has traditionally involved maximal surgical resection/debulking of the primary tumor (if feasible), followed by adjuvant radiotherapy over 6-8 weeks, with or without chemotherapy. The oral alkylating agent temozolomide was found to increase median survival when used in combination with radiotherapy, compared to radiotherapy alone, in patients with newly diagnosed GBM. However, expression of O6-methylguanine methyltransferase (MGMT) in GBM has been linked to poor patient outcome in patients treated with temozolomide.
The study drug, dianhydrogalactitol (VAL 083) is a bi-functional N7 DNA alkylating agent which has demonstrated cytotoxic activity that is independent of chemo-resistance due to expression of MGMT. This makes VAL-083 an ideal candidate to treat patients who are unlikely to respond to temozolomide due to MGMT expression in their GBM. Furthermore, VAL-083 acted as a radio-sensitizer at low (1 - 2.5μM) concentrations in all GBM cultures tested.
VAL-083 has been studied extensively in the United States by the National Cancer Institute. The NCI studies suggested that VAL-083 appeared to have activity in some types of cancer (lung and brain), including GBM; however, further VAL-083 research was not pursued in the US due to an increased focus on targeted biologic therapies during that era. VAL-083 has also been studied in the People's Republic of China, where it is currently approved and marketed for treatment of chronic myeloid leukemia and lung cancer. At present, VAL-083 is being studied in clinical trials in the United States as a third-line treatment option for patients with recurrent GBM following failure of surgery, radiation therapy, temozolomide and bevacizumab. Interim results support safety of VAL-083 in this population; to date, a regimen of 40mg/m2/d x 3 days IV in a 21 day cycle has been confirmed to be safe and well tolerated.
This phase 2, open-label, single arm study will be conducted in a dose-escalation cohort scheme to confirm the optimal dose of VAL-083, when administered concurrently with radiation therapy. Dose escalation will proceed in three sequential cohorts, consisting of patients receiving VAL-083 at 20, 30 and 40 mg/m2/d x 3 every 21 days.
This trial will be conducted in 2 parts. Part 1 will consist of 1) a 42-day induction period, during which patients will receive VAL-083 while undergoing radiation treatment at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks (for a total dose of 60 Gy), followed by 2) adjuvant maintenance therapy with VAL-083 alone, administered daily x 3 IV every 3 weeks at the same assigned dose, for a maximum of 8 maintenance cycles. Part 2 will comprise an expansion phase, in which VAL-083 will be studied in up to 20 additional subjects. The dose of VAL-083 that will be studied in Part 2 will be determined from Part 1.
Patients will undergo safety assessments including physical examinations, vital signs, hematology, serum chemistry, and urinalysis.
In both parts of the study, a pharmacokinetic study may be conducted at treatment Cycle 1 Day 1, in consenting patients. For patients consenting to CSF collection by lumbar puncture, a CSF sample will be obtained after completion of the Cycle 1, Day 3 VAL-083 infusion. These patients will also have a blood sample taken for VAL-083 plasma level after completion of drug infusion.
Response parameters will be evaluated according to the Response Assessment in NeuroOncology (RANO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAL-083 (Dianhydrogalactitol) | Experimental | Drug: VAL-083 (Dianhydrogalactitol)VAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Newly diagnosed histologically proven supratentorial GBM
- Tumor tissue specimens from the GBM surgery or open biopsy must be available for MGMT gene promoter status analysis and central pathology review.
- Documented unmethylated MGMT gene promoter status
- Males or females ≥18< 70 years of age.
- Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
Key exclusion criteria (18 listed)
- Prior chemotherapy within the last 5 years.
- Prior radiation therapy of the head.
- Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of VAL-083.
- Prior systemic anti-angiogenic therapy.
- Placement of Gliadel® wafer at surgery.
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 |
|---|---|---|
| VAL-083 (Dianhydrogalactitol)VAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts. | Drug | VAL-083 (Dianhydrogalactitol) |
Primary outcome
Efficacy evaluation of tumor response in patients, as measured by magnetic resonance imaging
Time frame: Every 42 days while receiving radiotherapy then every 63 days while remaining on study, from patient randomization until study discontinuation for up to 10 months
Tumor response assessment via MRI, as long as patient continues to demonstrate response or stable disease and tolerates therapy.
12 secondary outcomes
Safety evaluation of VAL-083 in combination with a standard radiation therapy, as determined by incidence of patient adverse events and changes in laboratory results, ECG and vital signs
Time frame: Every 30 days, from patient randomization through 28 days following last study treatment for up to 10 months
Ctrough
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Cmax
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Tmax
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
AUClast
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
AUCinf
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
CL/F
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Mean Residence Time
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Vz
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Lambda z
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
T½
Time frame: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Pharmacokinetic profile and dose-exposure relationship of VAL-083 in Cerebral Spinal Fluid (CSF)
Time frame: Once after completion of Cycle 1 Day 3 infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 41385182Guo C, Yang Q, Deng M, Qiu X, Wu S, Du X, Sai K, Dai Z, Chen Z, Zhang J, Lin F, Ke C, Xi S, Hu W, Zhou Z, Li J, Cao X, Liao Y, Lv Y, Brown D, Langlands J, Johnson G, Bacha J, Kwan C, Kanekal S, Schwartz R, Chen Z. VAL-083 is effective in patients with newly-diagnosed MGMT-unmethylated glioblastoma: report of phase II study. Discov Oncol. 2025 Dec 12;17(1):104. doi: 10.1007/s12672-025-04235-y.
- Individual participant dataSharing planned: No. The Clinical Study Report for this trial will be prepared and provided to U.S. F.D.A. as required by applicable regulatory requirement(s). The trial investigator will be provided a copy of their patient data captured in the electronic data base for this trial.
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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. This study is not recruiting at the moment.
Chen Zhong-ping, M.D., Ph.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAL-083 (Dianhydrogalactitol) in people with Glioma and Glioblastoma, run by Kintara Therapeutics, Inc. at 1 site in China.
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 15 inclusion and 18 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: finished, as of the sponsor's last update on 4 Sep 2025. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluation of tumor response in patients, as measured by magnetic resonance imaging (time frame: Every 42 days while receiving radiotherapy then every 63 days while remaining on study, from patient randomization until study discontinuation for up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050736, which also lists 1 linked publication.
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 4 Sep 2025.