A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients with Advanced or Recurrent Solid Tumors

BP1001 a liposome-incorporated Grb2 antisense oligodeoxynucleotide binds directly to and blocks Grb2 mRNA, thereby preventing Grb2 protein synthesis, leading to inhibition of cell proliferation of cancer cells overexpressing Grb2.

In this study, the sponsor and investigators want to learn:

• How much of the study can be given with an acceptable level of side effects
• The effects of the study (good and bad)
• How much of the study is absorbed into the blood and how fast it is removed
• If research tests can be used in the future to predict who will benefit from BP1001-A

This is a dose escalation/expansion study. Dose escalation (Part A) means that the amount of the study given will be increased in each group of research participants, to find the most appropriate dose for further study.  In the dose expansion part of the study (Part B), a larger number of people receive the study agent dose determined to be appropriate in the dose escalation part of the study.  The part and dose of the study you receive will be determined by when you enter the study.

The study treatment will be given in cycles.  Each cycle is 4 weeks (28 days). All participants in Part A and Part B will receive the study agent BP1001-A as two infusions per week (Days 1, 4, 8, 11, 15, 18, 22, and 25). Each infusion is given through a vein (IV) over 2 to 3 hours. If you are taking part in Part B, you will also receive paclitaxel on Days 1, 8, and 15. Each paclitaxel infusion is given IV over 1 hour. There is a break in paclitaxel administration in week 4. On the days both the study agent and Paclitaxel are given, Paclitaxel will be given first, followed by a 1 to 1.5 hour wait before the study agent infusion.