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A Study of GFH009 in Patients With Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04588922
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
ZhejiangGenfleet ( Zhejiang Genfleet Therapeutics Co., Ltd. )

Brief Summary:
GFH009 is a potent and highly selective CDK9 inhibitor. The study consists of a dose escalation and a dose expansion part. The purpose of this study is to investigate the safety and tolerability of GFH009 in relapsed/refractory hematologic malignancies [acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and lymphoma], will also explore the preliminary anti-tumor activities of GFH009 in the studied population.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: GFH009 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent in Patients With Relapsed/Refractory Hematologic Malignancies
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: GFH009 Drug: GFH009
In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. In the expansion part, patients will be assigned based on tumor type(s).

Primary Outcome Measures :
  1. Safety and Tolerability of GFH009: Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]
    The incidence of DLTs

  2. Safety and Tolerability of GFH009: adverse events (AEs) [ Time Frame: approximately 2 years ]
    The incidence and severity of all AEs

Secondary Outcome Measures :
  1. PK parameter AUC0-t (Area under the plasma concentration-time curve (from zero to the time of the last measurable concentration)) [ Time Frame: approximately 3 months ]
  2. PK parameter AUC0-∞ (Area under the plasma concentration-time curve (from zero to infinity) [ Time Frame: approximately 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL/SLL and lymphoma)
  2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except for patients with Gilbert's syndrome, who are included if total bilirubin is < 3 × ULN or if direct bilirubin is < 1.5 × ULN.

    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 × ULN.

  3. Amylase and lipase ≤1.5 × ULN
  4. Electrolytes and uric acid levels within normal limits (WNL) or correctable with medical intervention
  5. For women of childbearing potential, must consent to use two highly effective methods (i.e, total abstinence, placement of an intrauterine device) of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug; Men with a partner of childbearing potential, must consent to use two highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug.

Exclusion Criteria

  1. Patients with bulky disease who require cytoreductive therapy.
  2. Symptomatic central nervous system metastases or primary lymphoma such as primary CNS lymphoma, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy and are on a stable or decreasing dose of corticosteroids are eligible for study entry.
  3. Severe cardiovascular disease within 6 months of study entry, including any of the following:

    • Clinically significant heart disease such as congestive heart failure requiring treatment (NYHA class III or IV), LVEF < 45% as determined by MUGA scan or echocardiogram (ECHO), (if just with historical occasional low LVEF but without any symptoms or relevant medical history, and the LVEF at screening is > 45%, the subject is eligible), or clinically significant arrythmia.
    • History/evidence of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting).
    • QTcF ≥ 450 msec on screening ECG.
  4. Concurrent malignancy within 5 years (for AML patients, 2 years) prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma (excluding T1 lesions and CIS).
  5. Chronic or active hepatitis B or hepatitis C virus infection.
  6. History of HIV infection.
  7. Concomitant medications that are strong CYP3A4 inhibitors and strong inducers within 7 days of first dose. Avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pomelos, star citrus fruits or St. John's wort within 7 days of first dose.
  8. Medications that are known to prolong the QT interval are prohibited on this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04588922

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Contact: Dongmei Zhang, Medical Director +86 21 6882 1388

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United States, Texas
MD Anderson
Houston, Texas, United States, 77091
Sponsors and Collaborators
Zhejiang Genfleet Therapeutics Co., Ltd.
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Responsible Party: Zhejiang Genfleet Therapeutics Co., Ltd. Identifier: NCT04588922    
Other Study ID Numbers: GFH009X2101
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases