Solid Organ Tumors
Conditions
Brief summary
First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.
Interventions
DRUGBAL101553
Intravenous administration
Sponsors
Basilea Pharmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available:colorectal; gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer; ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative breast 3. Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125) 4. Life expectancy ≥ 12 weeks 5. Acceptable organ and marrow function at baseline (protocol defined laboratory parameters) 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 7. Other protocol-defined inclusion criteria may apply.
Exclusion criteria
1. Patients 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 2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease 3. Peripheral neuropathy ≥ CTCAE v4 grade 2 4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements 5. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control 6. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed as part of the screening examination. 7. Patients treated with a calcium channel blocker or who require combination of more than 2 antihypertensives to control blood pressure. 8. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553 | 28 day cycles | First-cycle dose limiting toxicities (DLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety and tolerability of BAL101553 treatment | 28 day cycles | Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments |
| To evaluate BAL101553 pharmacokinetics | 28 day cycles | BAL101553 and BAL27862 PK parameters including (but not limited to): Cmax (maximum observed plasma concentration), AUC (area under the concentration time curve), half-life, volume of distribution |
| To assess anti-tumor activity of BAL101553 | 28 day cycles | Response rate per RECIST guidelines |
| To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553 | 28 day cycles | Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers |
Countries
United Kingdom
Outcome results
None listed