Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNC105P · 1 trial · 1 indication
Phase I
Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
| Arm | Type | Description |
|---|---|---|
| Combination Arm A: Everolimus + BNC105P | ACTIVE_COMPARATOR | Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle |
| Sequential Arm B:Everolimus followed by BNC105P Monotherapy | ACTIVE_COMPARATOR | Sequential Arm B: Everolimus 10 mg, 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy. |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals |
| BNC105P | DRUG | BNC105P, up to 16 mg/m\^2 |
Inclusion Criteria: * Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma). * Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory. * Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (T...
BNC105P is an investigational small molecule being studied for the treatment of Renal Cell Carcinoma, specifically in patients with progressive metastatic clear cell renal cell carcinoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BNC105P is being developed by Bionomics Limited, a biopharmaceutical company. The company's American Depository Shares trade under the ticker symbol NEUP.
BNC105P is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use and is still undergoing clinical trials to evaluate its safety and efficacy.
BNC105P has one completed clinical trial, identified as NCT01034631. This Phase 1 study evaluated BNC105P in combination with everolimus, or following everolimus, for progressive metastatic clear cell renal cell carcinoma. The trial enrolled 154 participants across the United States, Australia, and Singapore.
No, BNC105P is not the same as everolimus. BNC105P is an investigational small molecule being studied as a potential treatment for renal cell carcinoma, while everolimus is an approved mTOR inhibitor used in cancer therapy. In the clinical trial NCT01034631, BNC105P was studied in combination with everolimus or following everolimus treatment.