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Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Phase 1, PHASE2 trial testing BAL101553 in Neoplasms in 43 participants. Completed in 7 August 2020.
| Lead sponsor | Basilea Pharmaceutica |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 24 August 2016 |
| Primary completion | 7 August 2020 |
| Estimated completion | 7 August 2020 |
| Sites | 6 locations across Switzerland |
Basilea Pharmaceutica — full company profile →
18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
First 28-day treatment cycle dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels
| Group | Value | 95% CI |
|---|---|---|
| MTD-determining Population in Phase 1 | 70 |
TEAEs are defined as all events occurring after BAL101553 treatment begins, up to 28 days after last study drug administration according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 - 30 mg/m² Cohort | 2 | |
| Phase 1 - 45 mg/m² Cohort | 2 | |
| Phase 1 - 70 mg/m² Cohort | 8 | |
| Phase 1 - 90 mg/m² Cohort | 3 | |
| Phase 2a - Ovarian Cancer Cohort | 9 | |
| Phase 2a - Recurrent Glioblastoma Cohort | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 - 30 mg/m² Cohort | 0 | |
| Phase 1 - 45 mg/m² Cohort | 0 | |
| Phase 1 - 70 mg/m² Cohort | 2 | |
| Phase 1 - 90 mg/m² Cohort | 2 | |
| Phase 2a - Ovarian Cancer Cohort | 3 | |
| Phase 2a - Recurrent Glioblastoma Cohort | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 - 30 mg/m² Cohort | 0 | |
| Phase 1 - 45 mg/m² Cohort | 0 | |
| Phase 1 - 70 mg/m² Cohort | 2 | |
| Phase 1 - 90 mg/m² Cohort | 1 | |
| Phase 2a - Ovarian Cancer Cohort | 0 | |
| Phase 2a - Recurrent Glioblastoma Cohort | 0 |
Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC0-last (of BAL101553 and BAL27862 has been assessed after a 48-hour IV infusion. Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² Cycle 1 Day 1 | 1430 | ± 43.9 |
| 30 mg/m² Cycle 2 Day 1 | 1310 | ± 47.6 |
| 45 mg/m² Cycle 1 Day 1 | 2260 | ± 43.9 |
| 45 mg/m² Cycle 2 Day 1 | 1890 | ± 13.3 |
| 70 mg/m² Cycle 1 Day 1 | 3560 | ± 45.9 |
| 70 mg/m² Cycle 2 Day 1 | 3550 | ± 43.1 |
| 90 mg/m² Cycle 1 Day 1 | 4810 | ± 74.0 |
| 90 mg/m² Cycle 2 Day 1 | 4150 | ± 67.5 |
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² Cycle 1 Day 1 | 1730 | ± 37.8 |
| 30 mg/m² Cycle 2 Day 1 | 2250 | ± 58.2 |
| 45 mg/m² Cycle 1 Day 1 | 3440 | ± 45.1 |
| 45 mg/m² Cycle 2 Day 1 | 3920 | ± 57.7 |
| 70 mg/m² Cycle 1 Day 1 | 7720 | ± 44.6 |
| 70 mg/m² Cycle 2 Day 1 | 6640 | ± 49.3 |
| 90 mg/m² Cycle 1 Day 1 | 10400 | ± 37.2 |
| 90 mg/m² Cycle 2 Day 1 | 10700 | ± 39.3 |
Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of BAL101553 and BAL27862. Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² Cycle 1 Day 1 | 43.0 | ± 22.9 |
| 30 mg/m² Cycle 2 Day 1 | 44.2 | ± 15.8 |
| 45 mg/m² Cycle 1 Day 1 | 69.3 | ± 19.3 |
| 45 mg/m² Cycle 2 Day 1 | 60.9 | ± 4.3 |
| 70 mg/m² Cycle 1 Day 1 | 119 | ± 34.5 |
| 70 mg/m² Cycle 2 Day 1 | 111 | ± 34.9 |
| 90 mg/m² Cycle 1 Day 1 | 174 | ± 63.6 |
| 90 mg/m² Cycle 2 Day 1 | 198 | ± 76.8 |
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² Cycle 1 Day 1 | 45.7 | ± 30.2 |
| 30 mg/m² Cycle 2 Day 1 | 52.7 | ± 45.8 |
| 45 mg/m² Cycle 1 Day 1 | 76.8 | ± 18.6 |
| 45 mg/m² Cycle 2 Day 1 | 76.2 | ± 43.1 |
| 70 mg/m² Cycle 1 Day 1 | 144 | ± 25.7 |
| 70 mg/m² Cycle 2 Day 1 | 120 | ± 41.2 |
| 90 mg/m² Cycle 1 Day 1 | 223 | ± 44.7 |
| 90 mg/m² Cycle 2 Day 1 | 199 | ± 40.4 |
Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of BAL101553 and BAL27862
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² Cycle 1 Day 1 | 39.0 | 24.0 – 48.0 |
| 30 mg/m² Cycle 2 Day 1 | 30.0 | 24.0 – 48.0 |
| 45 mg/m² Cycle 1 Day 1 | 29.0 | 4.03 – 30.0 |
| 45 mg/m² Cycle 2 Day 1 | 27.1 | 24.2 – 30.0 |
| 70 mg/m² Cycle 1 Day 1 | 4.00 | 1.00 – 24.1 |
| 70 mg/m² Cycle 2 Day 1 | 1.56 | 1.00 – 4.05 |
| 90 mg/m² Cycle 1 Day 1 | 2.53 | 1.03 – 46.5 |
| 90 mg/m² Cycle 2 Day 1 | 1.17 | 1.00 – 3.95 |
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² Cycle 1 Day 1 | 48.0 | 30.1 – 48.0 |
| 30 mg/m² Cycle 2 Day 1 | 48.0 | 24.0 – 52.9 |
| 45 mg/m² Cycle 1 Day 1 | 48.0 | 29.0 – 48.1 |
| 45 mg/m² Cycle 2 Day 1 | 47.5 | 47.2 – 47.9 |
| 70 mg/m² Cycle 1 Day 1 | 47.6 | 29.1 – 52.1 |
| 70 mg/m² Cycle 2 Day 1 | 46.6 | 7.5 – 54.7 |
| 90 mg/m² Cycle 1 Day 1 | 46.2 | 23.8 – 47.5 |
| 90 mg/m² Cycle 2 Day 1 | 47.4 | 46.7 – 47.4 |
Ratio of AUCs of avanbulin after oral and IV administration (relative bioavailability) of BAL101553 (lisavanbulin) which is the prodrug of avanbulin (BAL27862)
| Group | Value | 95% CI |
|---|---|---|
| 30 mg/m² | 1.11 | ± 0 |
| 45 mg/m² | 1.32 | ± 0 |
| 70 mg/m² | 0.796 | ± 18.9 |
| 90 mg/m² | 0.893 | ± 0 |
The objective response rate (ORR) was calculated using the efficacy evaluable populations (EEPs in Phase 2a) and the full analysis population (FAP in Phase 1 and Phase 2a) based on RECIST v1.1 guidelines (defines criteria for the radiological assessment in tumor response) for patients with solid tumors (excluding GBM (glioblastoma)) and RANO criteria (assessment Incorporating MRI and clinical factors) for patients with GBM. ORR = Rate of complete and partial responses
| Group | Value | 95% CI |
|---|---|---|
| Phase 1- in the FAP | 1 | |
| Phase 2a - Patients With Ovarian Cancer in the FAP | 0 | |
| Phase 2a - Patients With Ovarian Cancer in the EEP | 0 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the FAP | 0 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the EEP | 0 | |
| Phase 1- in the FAP | 0 | |
| Phase 2a - Patients With Ovarian Cancer in the FAP | 0 | |
| Phase 2a - Patients With Ovarian Cancer in the EEP | 0 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the FAP | 1 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the EEP | 1 | |
| Phase 1- in the FAP | 3 | |
| Phase 2a - Patients With Ovarian Cancer in the FAP | 4 | |
| Phase 2a - Patients With Ovarian Cancer in the EEP | 3 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the FAP | 2 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the EEP | 1 | |
| Phase 1- in the FAP | 15 | |
| Phase 2a - Patients With Ovarian Cancer in the FAP | 7 | |
| Phase 2a - Patients With Ovarian Cancer in the EEP | 5 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the FAP | 9 | |
| Phase 2a - Patients With Recurrent Glioblastoma in the EEP | 6 |
Time frame: First dose of study drug through 28 days after the administration of the last dose. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 1 - 30 mg/m² Cohort | Phase 1 - 45 mg/m² Cohort | Phase 1 - 70 mg/m² Cohort | Phase 1 - 90 mg/m² Cohort | Phase 2a - Ovarian Cancer … | Phase 2a - Recurrent Gliob… |
|---|---|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Brain oedema | Nervous system disorders | — | — | — | — | — | — |
| Nervous system disorder | Nervous system disorders | — | — | — | — | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — | — | — | — | — |
| Partial seizures | Nervous system disorders | — | — | — | — | — | — |
| Seizure | Nervous system disorders | — | — | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Anal haemorrhage | Gastrointestinal disorders | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Device related infection | Infections and infestations | — | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — | — |
| Femoral neck fracture | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Bladder neoplasm surgery | Surgical and medical procedures | — | — | — | — | — | — |
| Haematoma | Vascular disorders | — | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — | — |
| Vena cava thrombosis | Vascular disorders | — | — | — | — | — | — |
| Asthenia | General disorders | — | — | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Thrombosis in device | Product Issues | — | — | — | — | — | — |
| Reaction | System | Phase 1 - 30 mg/m² Cohort | Phase 1 - 45 mg/m² Cohort | Phase 1 - 70 mg/m² Cohort | Phase 1 - 90 mg/m² Cohort | Phase 2a - Ovarian Cancer … | Phase 2a - Recurrent Gliob… |
|---|---|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — | — | — |
| Troponin T increased | Investigations | — | — | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — |
| Proctalgia | Gastrointestinal disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Haematoma | Vascular disorders | — | — | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — | — | — |
| Hallucination | Psychiatric disorders | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — | — | — | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — | — | — | — | — |
| Creatinine renal clearance decreased | Investigations | — | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — | — |
| Weight increased | Investigations | — | — | — | — | — | — |
| White blood cell count decreased | Investigations | — | — | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — | — | — |
Most-reported serious reactions: Fall, Brain oedema, Nervous system disorder, Neuropathy peripheral, Partial seizures, Seizure, Somnolence, Abdominal pain.
Data from ClinicalTrials.gov NCT02895360 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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