Bio-Path Holdings, Inc.
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.
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 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. 4. For the dose expansion phase, participants must have recurrent or persistent epitheli…
Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.
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.