A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy
Bio-Path Holdings, Inc.
Summary
The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
Description
Improvement of clinical benefit in fragile AML patients while maintaining tolerability is an important area of further clinical development. Modern aggressive combination chemotherapy can induce CR in a significant proportion of patients with previously untreated AML, but relapse occurs in most unless patients undergo intensive allogeneic hematopoietic stem cell transplantation. Novel therapies are needed for these patients The Grb2 gene has been mapped to the human chromosome region 17q22-qter, a region that is duplicated in leukemias and solid tumors, which may result in an increased copy n…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 contraception during the study and for 30 days after the last dose of study drug or decitabine 3. Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine 4. Histologically documented diagnosis (based on the…
Interventions
- DrugBP1001 in combination with Ventoclax plus decitabine
BP1001 in combination with Ventoclax plus decitabine
- DrugBP1001 plus decitabine
BP1001 plus decitabine in ventoclax intolerant or resistant subjects
Locations (9)
- UCLA Medical CenterLos Angeles, California
- Georgia Cancer Center at Augusta UniversityAugusta, Georgia
- University of Kansas Cancer CenterFairway, Kansas
- New Jersey Hematology Oncology AssociatesBrick, New Jersey
- Laura & Isaac Pe lmutter Cancer Center at NYU Langone HealthNew York, New York
- Weill Cornell Medical College - New York - Presbyterian HospitalNew York, New York