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Also known as BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)
BP1001-A · 1 trial · 6 indications
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
Identify MTD based on dose limiting toxicities (DLT) of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade TEAE of escalating doses of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade TEAE of BP1001-A in combination with paclitaxel using non-hematologic and hematologic measures per NCI CTCAE criteria
| Arm | Type | Description |
|---|---|---|
| BP1001-A monotherapy | EXPERIMENTAL | Dose escalation of BP1001-A monotherapy |
| BP1001-A and Paclitaxel | EXPERIMENTAL | Dose expansion of selected dose of BP1001-A with paclitaxel |
| Name | Type | Description |
|---|---|---|
| BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) | DRUG | Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles. |
| BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel | DRUG | Dose expansion of BP1001-A IV twice weekly (Maximum tolerated dose or Maximum admistered dose) plus paclitaxel IV weekly for 4 weeks (28-day cycle) for 6 cycles. |
Inclusion Criteria: 1. All participants, ≥ 18 years of age, with histologic evidence of advanced or recurrent solid tumors, who are not candidates for regimens or protocol treatments known to confer clinical benefit. 2. ECOG Performance Status Score of 0 or 1. 3. Participants must be willing to und...