Clinical Trials /

A Study of GFH009 in Patients With Hematologic Malignancies

NCT04588922

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of GFH009 in Patients With Hematologic Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GFH009X2101
  • NCT ID: NCT04588922

Conditions

  • Hematologic Malignancies

Interventions

DrugSynonymsArms
GFH009GFH009

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
GFH009Experimental
  • GFH009

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability of GFH009: Dose Limiting Toxicities (DLTs)
Time Frame:21 days
Safety Issue:
Description:The incidence of DLTs

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:PK parameter AUC0-∞ (Area under the plasma concentration-time curve (from zero to infinity)
Time Frame:approximately 3 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Zhejiang Genfleet Therapeutics Co., Ltd

Last Updated

October 15, 2020