BP1002

P1, N=30, Recruiting, Bio-Path Holdings, Inc. | Trial completion date: Jan 2025 --> Jan 2026

P1, N=30, Recruiting, Bio-Path Holdings, Inc. | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Sep 2023 --> Sep 2024

P1, N=48, Recruiting, Bio-Path Holdings, Inc. | Not yet recruiting --> Recruiting

P1, N=48, Not yet recruiting, Bio-Path Holdings, Inc. | Initiation date: Apr 2022 --> Jul 2022

P1, N=30, Recruiting, Bio-Path Holdings, Inc. | Trial completion date: Aug 2022 --> Jan 2024 | Trial primary completion date: Feb 2022 --> Sep 2023

P1, N=48, Not yet recruiting, Bio-Path Holdings, Inc. | Initiation date: Jan 2022 --> Apr 2022

P1, N=48, Not yet recruiting, Bio-Path Holdings, Inc.

Our data indicate that, despite expressing higher levels of anti-apoptotic proteins, venetoclax-resistant cells are sensitive to the BP1002 plus decitabine combination. These promising preclinical results suggest that the BP1002 plus decitabine combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.

P1, N=30, Recruiting, Bio-Path Holdings, Inc. | Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Feb 2021 --> Feb 2022

P1, N=30, Not yet recruiting, Bio-Path Holdings, Inc. | Initiation date: Feb 2020 --> Jun 2020

The dose below that will be the maximum tolerated dose (MTD). The RP2D will be determined using the MTD data and all information regarding safety, biological activity, PK and pharmacodynamics.Primary objectives: To determine•Safety and tolerability of escalating doses of BP1002•RP2D of BP1002•PK of BP1002•BP1002 activity on Bcl-2 expressionSecondary objectives: To obtain evidence of tumor response (overall response rate = complete remission + partial remission + minor response), and estimates for other response parameters (time to progression, progression-free survival, event-free survival)Exploratory objectives: To correlate treatment response with biological activity, cytogenetic and molecular characteristicsSafety assessments will include identification of DLTs, serious adverse events, treatment-emergent adverse events and treatment-emergent laboratory abnormalitiesResponse assessments will be determined per the 2018 International Workshop Group on CLL (iwCLL) response criteria, the International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017), or the Eighth International Workshop for Waldenströms Macroglobulinemia response criteria.