Single-agent, open-label, multi-center sequential dose escalation and expansion study of
BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced
or recurrent solid tumors or recurrent glioblastoma.
Drug: BAL101553 at MTD
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Full eligibility criteria for NCT02895360
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Age ≥ 18 years
Phase 1: Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor, who failed standard therapy or for whom no effective standard therapy is available. Phase 2a: Patients with platinum-resistant/refractory ovarian, fallopian tube or primary peritoneal cancer (high-grade serous, endometrioid, or carcinosarcoma histotypes) or glioblastoma in first relapse.
Patients with solid tumors must have measurable disease according to Response Evaluation Criteria in Solid Tumors [RECIST] v1.1. Patients with recurrent glioblastoma must have measurable disease defined by contrast-enhancing magnetic resonance imaging.
Life expectancy ≥ 12 weeks
Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
Patients with solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and patients with recurrent glioblastoma must have an ECOG performance status ≤ 2.
Other protocol-defined inclusion criteria may apply.
Patients with 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 glioblastoma 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, or have been treated previously with bevacizumab.
Patients who have had prior exposure to BAL101553.
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) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 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.
All locations for NCT02895360
Oncology Institute of Southern Switzerland; Ospedale Regionale San Giovanni Bellinzona e Valli
Bellinzona, Switzerland, 6500
Bern, Switzerland, 3010
Cantonal Hospital of Grisons, Department of Oncology/ Haematology
Chur, Switzerland, 7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Cantonal Hospital of St. Gallen, Dep. Medical Oncology & Hematology
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8091
View full eligibility
Tris trial is registered with FDA with number: NCT02895360. The sponsor of the trial is Basilea Pharmaceutica and it is looking for 43 volunteers for the current phase.
Official trial title: An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma
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