This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.
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.
ECOG Performance Status Score of 0 or 1.
Participants must be willing to undergo pre-treatment biopsies. Participants who complete 1 cycle of treatment will undergo post-treatment biopsies. Post-treatment biopsies will be offered to participants who do not complete 1 cycle of treatment.
For the dose expansion phase, participants must have recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor and must be participants for whom single agent paclitaxel would be considered a reasonable treatment option.
For the dose expansion phase, participants must not have low grade serous ovarian carcinoma or mucinous ovarian carcinoma.
For the dose expansion phase, participants must wait at least two weeks after receiving any strong inhibitor, inducer, or substrate of both CYP3A4 and CYP2C8 before investigational drug administration.
Participants who had previous bone marrow or hematopoietic stem cell transplant.
Participants may not be receiving any other investigational agents.
Sequential
BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)
DrugDose 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
DrugDose 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.
Identify Dose Limiting Toxicity (DLT) of BP1001-A
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
Identify maximum tolerated dose (MTD) of BP1001-A
Identify MTD based on dose limiting toxicities (DLT) of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A
Identify and grade TEAE of escalating doses of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A in combination with paclitaxel
Identify and grade TEAE of BP1001-A in combination with paclitaxel using non-hematologic and hematologic measures per NCI CTCAE criteria
Frequency and severity of Adverse Events (AEs) of BP1001-A monotherapy and in combination with paclitaxel
Determine frequency and grade of AEs per NCI CTCAE criteria
Determine objective response rate (ORR) by biopsy
Determine ORR by tumor biopsy using Response Criteria in Solid Tumors (RECIST)
Determine objective response rate (ORR) by imaging
Determine ORR by MRI or CT imaging using Response Criteria in Solid Tumors (RECIST)
Describe duration of overall response (OR)
Describe duration of OR using tumor biopsy per RECIST
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