Who is sponsoring NCT03250299?

NCT03250299 is sponsored by Basilea Pharmaceutica.

What condition does NCT03250299 study?

NCT03250299 studies Glioblastoma, MGMT-Unmethylated Glioblastoma.

Is NCT03250299 still recruiting?

NCT03250299 is currently terminated. Last updated 24 June 2024.

Are results published for NCT03250299?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-24 · How we verify

NCT03250299

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Terminated Phase 1 Results posted Last updated 24 June 2024

What this trial tests

Phase 1 trial testing Microtubule-Targeted Agent BAL101553 in Glioblastoma in 26 participants. Terminated before completion.

Timeline

15 December 2017

Primary endpoint
3 June 2022

24 August 2022

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	15 December 2017
Primary completion	3 June 2022
Estimated completion	24 August 2022
Sites	8 locations across United States

Drugs / interventions tested

Microtubule-Targeted Agent BAL101553 — full drug profile →
Radiation Therapy — full drug profile →

Conditions studied

Glioblastoma — all drugs for Glioblastoma →
MGMT-Unmethylated Glioblastoma — all drugs for MGMT-Unmethylated Glioblastoma →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

18 and older, any sex, with Glioblastoma or MGMT-Unmethylated Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Dose-Limiting Toxicities (DLTs) for Each Maximal Tolerated Dose (MTD)-Determining Dose Cohort Primary · Up to 10 weeks

A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to BAL101553 or the combination of BAL101553 and radiation.

Group	Value	95% CI
BAL101553 4 mg MTD-determining Cohort	0
BAL101553 6 mg MTD-determining Cohort	0
BAL101553 8 mg MTD-determining Cohort	1
BAL101553 12 mg MTD-determining Cohort	1
BAL101553 15 mg MTD-determining Cohort	0

Number of Patients With Grade 3 to Grade 5 Adverse Events (AEs) Secondary · up to 10 weeks

Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )

Group	Value	95% CI
BAL101553 4 mg Cohort	1
BAL101553 6 mg Cohort	2
BAL101553 8 mg Cohort	1
BAL101553 12 mg Cohort	2
BAL101553 15 mg Cohort	1
BAL101553 4 mg Cohort	1
BAL101553 6 mg Cohort	1
BAL101553 8 mg Cohort	1
BAL101553 12 mg Cohort	1
BAL101553 15 mg Cohort	0
BAL101553 4 mg Cohort	3
BAL101553 6 mg Cohort	2
BAL101553 8 mg Cohort	5
BAL101553 12 mg Cohort	2
BAL101553 15 mg Cohort	3

Overall Survival (OS) Time Secondary · Day 1 to date of death - up to 1679 days (4.6 years)

OS was defined as the time from Day 1 dosing to the date of death. Patients who have not died at study closure were censored at the time of last known alive.

Group	Value	95% CI
All BAL101553 Treated Patients	383.0	273.0 – 552.0

Progression Free Survival (PFS) Time Secondary · Day 1 to date of disease progression - 1092 days (3.0 years)

PFS was the interval between Day 1 dosing and the earliest date of progression. Progression was defined as: an increase in tumor size of more than 25% or the appearance of new lesions on MRI scans, significant clinical deterioration not attributable to causes other than the tumor, or death from any cause. Patients who have not progressed or died at study closure were censored at the time of their last assessment without progression.

Group	Value	95% CI
All BAL101553 Treated Patients	247.0	128.0 – 366.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BAL101553 4 mg Cohort

Serious: 2/5 (40%)

Deaths: 5/5

BAL101553 6 mg Cohort

Serious: 3/5 (60%)

Deaths: 5/5

BAL101553 8 mg Cohort

Serious: 2/7 (29%)

Deaths: 4/7

BAL101553 12 mg Cohort

Serious: 2/5 (40%)

Deaths: 4/5

BAL101553 15 mg Cohort

Serious: 1/4 (25%)

Deaths: 0/4

Serious adverse events (23 terms)

Reaction	System	BAL101553 4 mg Cohort	BAL101553 6 mg Cohort	BAL101553 8 mg Cohort	BAL101553 12 mg Cohort	BAL101553 15 mg Cohort
Aphasia	Nervous system disorders	—	—	—	—	—
Brain oedema	Nervous system disorders	—	—	—	—	—
Cognitive disorder	Nervous system disorders	—	—	—	—	—
Dysarthria	Nervous system disorders	—	—	—	—	—
Facial paresis	Nervous system disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Hydrocephalus	Nervous system disorders	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—
Encephalitis	Infections and infestations	—	—	—	—	—
Peritonitis	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Embolism	Vascular disorders	—	—	—	—	—
Gait disturbance	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—

Other adverse events (154 terms — click to expand)

Reaction	System	BAL101553 4 mg Cohort	BAL101553 6 mg Cohort	BAL101553 8 mg Cohort	BAL101553 12 mg Cohort	BAL101553 15 mg Cohort
Fatigue	General disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Pain	General disorders	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—
Troponin I increased	Investigations	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—
Cognitive disorder	Nervous system disorders	—	—	—	—	—
Hemiparesis	Nervous system disorders	—	—	—	—	—
Memory impairment	Nervous system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Micturition urgency	Renal and urinary disorders	—	—	—	—	—
Urinary incontinence	Renal and urinary disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Radiation skin injury	Injury, poisoning and procedural complications	—	—	—	—	—
Depilation	Surgical and medical procedures	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Agitation	Psychiatric disorders	—	—	—	—	—
Irritability	Psychiatric disorders	—	—	—	—	—

Most-reported serious reactions: Aphasia, Brain oedema, Cognitive disorder, Dysarthria, Facial paresis, Headache, Hydrocephalus, Lethargy.

Data from ClinicalTrials.gov NCT03250299 adverse events section.

Sponsor's own description

This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase (MGMT) promoter unmethylated glioblastoma (GBM). Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with GBM.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.
Wen PY, Weller M, Lee EQ, Alexander BM, et al · · 2020 · cited 908× · PMID 32328653 · DOI 10.1093/neuonc/noaa106
Current Challenges and Opportunities in Treating Glioblastoma.
Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
Updates in IDH-Wildtype Glioblastoma.
Melhem JM, Detsky J, Lim-Fat MJ, Perry JR. · · 2022 · cited 55× · PMID 35641844 · DOI 10.1007/s13311-022-01251-6
Glioma‑neuronal interactions in tumor progression: Mechanism, therapeutic strategies and perspectives (Review).
Hua T, Shi H, Zhu M, Chen C, et al · · 2022 · cited 28× · PMID 35856439 · DOI 10.3892/ijo.2022.5394
Treating ICB-resistant glioma with anti-CD40 and mitotic spindle checkpoint controller BAL101553 (lisavanbulin).
Genoud V, Espinoza FI, Marinari E, Rochemont V, et al · · 2021 · cited 15× · PMID 34403371 · DOI 10.1172/jci.insight.142980
Preclinical modeling in glioblastoma patient-derived xenograft (GBM PDX) xenografts to guide clinical development of lisavanbulin-a novel tumor checkpoint controller targeting microtubules.
Burgenske DM, Talele S, Pokorny JL, Mladek AC, et al · · 2022 · cited 13× · PMID 34232318 · DOI 10.1093/neuonc/noab162
A Phase 1 study of BAL101553, a novel tumor checkpoint controller targeting microtubules, administered as 48-h infusion in adult patients with advanced solid tumors.
Joerger M, Stathis A, Metaxas Y, Hess D, et al · · 2020 · cited 9× · PMID 31471863 · DOI 10.1007/s10637-019-00850-z
Phase 1/2a trial of intravenous BAL101553, a novel controller of the spindle assembly checkpoint, in advanced solid tumours.
Kristeleit R, Evans J, Molife LR, Tunariu N, et al · · 2020 · cited 8× · PMID 32741975 · DOI 10.1038/s41416-020-1010-8

Verify or expand the search:

Other recruiting trials for Glioblastoma

Currently open trials in the same condition.

NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
NCT05653635 — Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study · Phase 2 · recruiting
NCT07480941 — Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma · Phase 1 · recruiting
NCT07448480 — Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas · active not recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

NCT06961708 — A Study of Fosmanogepix in Healthy Adult Chinese Subjects · Phase 1 · completed
NCT06808646 — A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin · Phase 1 · completed
NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas · Phase 3 · recruiting
NCT06665555 — Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03250299 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 24 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03250299.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing