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A Study of GFH009 in Patients With Hematologic Malignancies

Sponsor
Zhejiang Genfleet Therapeutics Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04588922
Collaborator
(none)
80
Enrollment
17
Locations
1
Arm
37.7
Anticipated Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 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
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability of GFH009: Dose Limiting Toxicities (DLTs) [21 days]

    The incidence of DLTs

  2. Safety and Tolerability of GFH009: adverse events (AEs) [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)) [approximately 3 months]

  2. PK parameter AUC0-∞ (Area under the plasma concentration-time curve (from zero to infinity) [approximately 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

  1. Amylase and lipase ≤1.5 × ULN

  2. Electrolytes and uric acid levels within normal limits (WNL) or correctable with medical intervention

  3. 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.

  1. 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).

  2. Chronic or active hepatitis B or hepatitis C virus infection.

  3. History of HIV infection.

  4. 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.

  5. Medications that are known to prolong the QT interval are prohibited on this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
2 Clinical Research Alliance, Inc. Lake Success New York United States 11042
3 New York - Presbyterian Hospital New York New York United States 10032
4 MD Anderson Houston Texas United States 77091
5 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China
6 Anhui Provincial Hospital Hefei Anhui China
7 Affiliated Cancer Hospital of Chongqing University Chongqing Chongqing China
8 Cancer prevention and treatment center of Sun Yat sen University Guangzhou Guangdong China
9 Guangdong Provincial People's Hospital Guangzhou Guangdong China
10 Affiliated Hospital of Hebei University Baoding Hebei China
11 Henan Cancer Hospital Zhengzhou Henan China 450000
12 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China
13 The First Affiliated Hospital Of Nanchang University Nanchang Jiangxi China
14 Linyi Cancer Hospital Linyi Shandong China
15 Blood disease hospital, Chinese Academy of Medical Science Tianjin Tianjin China 300000
16 The Second Affiliated hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310000
17 Shengjing Hospital Affiliated to China Medical University Shenyang China

Sponsors and Collaborators

  • Zhejiang Genfleet Therapeutics Co., Ltd.

Investigators

  • Study Chair: Alan Zhu, GenFleet Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhejiang Genfleet Therapeutics Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04588922
Other Study ID Numbers:
  • GFH009X2101
First Posted:
Oct 19, 2020
Last Update Posted:
Aug 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms

Study Results

No Results Posted as of Aug 3, 2022