A Study of GFH009 in Patients With Hematologic Malignancies
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ClinicalTrials.gov Identifier: NCT04588922 |
Recruitment Status :
Recruiting
First Posted : October 19, 2020
Last Update Posted : September 1, 2023
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Sponsor:
Genfleet Therapeutics (Shanghai) Inc.
Collaborator:
Sellas Life Sciences Group
Information provided by (Responsible Party):
Genfleet Therapeutics (Shanghai) Inc.
Tracking Information | |||||||||
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First Submitted Date ICMJE | September 28, 2020 | ||||||||
First Posted Date ICMJE | October 19, 2020 | ||||||||
Last Update Posted Date | September 1, 2023 | ||||||||
Actual Study Start Date ICMJE | May 10, 2021 | ||||||||
Estimated Primary Completion Date | June 30, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of GFH009 in Patients With Hematologic Malignancies | ||||||||
Official Title ICMJE | A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies | ||||||||
Brief Summary | GFH009 is a potent and highly selective CDK9 inhibitor. To assess the safety, tolerability, and antitumor activity of single agent GFH009, this study consists of two dose escalation groups in patients with relapsed/refractory acute myeloid leukemia (Group 1) and in patients with relapsed/refractory lymphomas (Group 2). The safety, tolerability, and antitumor activity of GFH009 in combination with venetoclax and azacitidine in patients with relapsed/refractory acute myeloid leukemia (AML) who have relapsed on or are refractory to venetoclax-based regimens will also be assessed (Group 3). | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hematologic Malignancies | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
135 | ||||||||
Original Estimated Enrollment ICMJE |
50 | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2024 | ||||||||
Estimated Primary Completion Date | June 30, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04588922 | ||||||||
Other Study ID Numbers ICMJE | GFH009X2101 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Genfleet Therapeutics (Shanghai) Inc. | ||||||||
Original Responsible Party | Zhejiang Genfleet Therapeutics Co., Ltd. | ||||||||
Current Study Sponsor ICMJE | Genfleet Therapeutics (Shanghai) Inc. | ||||||||
Original Study Sponsor ICMJE | Zhejiang Genfleet Therapeutics Co., Ltd. | ||||||||
Collaborators ICMJE | Sellas Life Sciences Group | ||||||||
Investigators ICMJE |
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PRS Account | Genfleet Therapeutics (Shanghai) Inc. | ||||||||
Verification Date | June 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |