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
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
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
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
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.