Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Liposomal Grb-2, L-Grb-2, BP-100-1.01
BP1001 · 2 trials · 5 indications
Assess whether the combination of BP1001 and Ventoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than Ventoclax + decitabine alone (by historical comparison) with untreated AML that cannot or elect not to be treated with more intensive chemotherapy
Assess whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
Evaluate toxicity, tolerance, and MTD of escalating doses of BP1001
Evaluate safety and toxicity of the combination of BP1001 and concurrent LDAC using non-hematologic and hematologic measures per NCI CTCAE criteria.
| Arm | Type | Description |
|---|---|---|
| Untreated AML | EXPERIMENTAL | BP1001 in combination with Ventoclax plus decitabine |
| Refractory/Relapsed AML | EXPERIMENTAL | BP1001 in combination with Ventoclax plus decitabine |
| Refractory/Relapsed AML (ventoclax-intolerant or resistant) | EXPERIMENTAL | BP1001 + decitabine combination in patients who are resistant or intolerant of venetoclax-based treatment, or considered not optimal candidates for a venetoclax-based therapy. |
| BP1001 | EXPERIMENTAL | Subjects are treated with open-label study drug (BP1001) in a dose-escalation model. |
| BP1001 in combination with LDAC | EXPERIMENTAL | AML subjects are treated with open-label escalating study drug (BP1001) in combination with low dose ara-C (LDAC) |
| Name | Type | Description |
|---|---|---|
| BP1001 in combination with Ventoclax plus decitabine | DRUG | BP1001 in combination with Ventoclax plus decitabine |
| BP1001 plus decitabine | DRUG | BP1001 plus decitabine in ventoclax intolerant or resistant subjects |
| BP1001 | DRUG | Study drug (BP1001) is constituted in normal saline, administered by IV on twice weekly for 28 days. |
| BP1001 in combination with LDAC | DRUG | Study drug (BP1001) is constituted in normal saline, administered by IV twice weekly for 28 days. Low dose ara-C (LDAC) is self administered twice daily for 10 consecutive days during the 28 day cycle. |
Inclusion Criteria At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study: 1. Adults ≥18 years of age 2. Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of ...