Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma
Neoplasms
About this trial
This is an interventional treatment trial for Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
Patients who have in the
Phase 1 portion either of the following:
- a histologically- or cytologically confirmed advanced or recurrent solid tumor, who failed standard therapy, or for whom no effective standard therapy is available to them
- histologically-confirmed GBM or high-grade glioma, with progressive or recurrent disease after prior radiotherapy, with or without chemotherapy. This will also include patients with histologically-confirmed low-grade glioma who present with unequivocal evidence by imaging of transformation to high-grade glioma/GBM.
Phase 2 portion: Recurrent, histologically confirmed, glioblastoma with tumor tissue positive for EB1; eligible are patients with de novo glioblastoma after prior radical chemo-radiotherapy or secondary glioblastoma after prior chemotherapy or radiotherapy.
- Patients must have measurable disease.
- Life expectancy ≥ 12 weeks
- Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
- Patients with advanced solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and patients with recurrent or progressive glioblastoma must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patients with advanced or recurrent solid tumors who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies.
Patients with recurrent or progressive GBM or high-grade glioma who have: received radiotherapy within 12 weeks, unless there is a new area of enhancement consistent with recurrent tumor outside the radiation field, or there is histological confirmation of unequivocal tumor progression; received administration of prior antitumor chemotherapy within 4 weeks, or within 6 weeks for nitrosoureas; undergone surgical resection within 4 weeks or a stereotactic biopsy/core biopsy within 1 week prior to starting study drug.
- Patients who have had prior exposure to BAL1015533.
- Inability to swallow oral medication
- Increase in steroid dose in GBM or high-grade glioma patients within 5 days prior to first study-drug administration or requirement for > 6 mg/day dexamethasone or equivalent for symptom control.
- Patients with gastrointestinal disease or those who have had a procedure that is expected to interfere with the oral absorption or tolerance of BAL101553
- Symptomatic brain metastases or leptomeningeal disease, indicative of active disease, in patients with advanced or recurrent solid tumors.
- Peripheral neuropathy ≥ CTCAE grade 2.
- Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
- Systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at the screening visit.
- Blood pressure (BP) combination treatment with more than two antihypertensive medications.
- Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- UZ Leuven
- Klinikum der Goethe-Universität Frankfurt
- Universitätsklinikum Heidelberg
- Universitätsklinikum Regensburg
- Universitätsklinikum Tübingen
- Universitätsspital Basel
- Inselspital Universitätsspital Bern
- Kantonsspital St. Gallen
- Universitätsspital Zürich
- Beatson West of Scotland Cancer Centre
- University College London NHS Foundation Trust
- Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
- Royal Marsden Hospital
Arms of the Study
Arm 1
Experimental
Drug: BAL101553
Oral daily administration of BAL101553