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 renal cell carcinoma, the most common form of kidney cancer. It has been evaluated specifically in patients with progressive metastatic clear cell renal cell carcinoma, a subtype of the disease. It is not approved for any indication and remains in clinical development.
BNC105P is being developed by Neuphoria Therapeutics Inc., which trades under the ticker NEUP. The company is the sponsor of the clinical program evaluating the drug in renal cell carcinoma.
BNC105P is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency for renal cell carcinoma or any other indication.
BNC105P has been studied in one completed Phase 1 trial, NCT01034631, titled BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma. The trial enrolled 154 patients across the United States, Australia, and Singapore and used an active-controlled, randomized design.
The Phase 1 trial NCT01034631 was a randomized, active-controlled study that evaluated BNC105P in combination with everolimus and following everolimus in patients with progressive metastatic clear cell renal cell carcinoma. It enrolled 154 patients aged 18 years and older, including all sexes, and was conducted in the United States, Australia, and Singapore.