- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05934513
A Study of GFH009 Monotherapy in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
February 21, 2024 updated by: Zhejiang Genfleet Therapeutics Co., Ltd.
A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
This is a multicentre, open-label phase Ib/II study.
The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
95
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin Li
- Phone Number: +86 21 6882 1388
- Email: jli@genfleet.com
Study Contact Backup
- Name: Yuting Peng
- Phone Number: +8613730813620
- Email: ytpeng@genfleet.com
Study Locations
-
-
Guangdong
-
Guanzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Zhiming Li
- Phone Number: 137191891722
- Email: lzmsysu@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female ≥ 18 years and ≤ 75 years.
- Written informed consent must be obtained prior to any screening procedures.
- Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
- Must have received and failed at least 2 but no more than 5 prior lines of therapies .
- Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
- Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.
- Eastern Cooperative Oncology Group performance status of ≤ 2.
- Adequate haematologic and organ function at screening.
- Life expectancy ≥ 12 week.
- Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and < Grade 2 sensory neuropathy.
- For women of childbearing potential, she must consent to use highly effective methods 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 highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug
Exclusion Criteria:
- Diagnosis of Cutaneous T-cell lymphoma .
- Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Patients with severe hemophagocytic syndrome at screening.
- Presence of uncontrolled third space effusion
- Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug; or undergone major surgery with 4 weeks; or received targeted therapy within 4 weeks or 5 half-lives whichever is shorter; or received immunotherapy.
- History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.
- Attend other clinical trial within 2 weeks prior to starting study drug.
- History of previous exposure to any other CDK9 inhibitor.
- Concurrent malignancy within 5 years prior to entry
- Uncontrolled pulmonary fibrosis, active lung diseases or interstitial lung disease.
- Severe cardiovascular disease
- Subjects with high risk of gastrointestinal hemorrhage.
- Uncontrolled infective diseases.
- Ongoing therapy with corticosteroids greater than 20 mg of prednisone or its equivalent per day and the duration of treatment was more than 14 days.
- Concomitant medications that are strong CYP3A4 inhibitors or strong inducers within 7 days prior to the 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.
- Major surgery within 4 weeks prior to study entry or surgery is under schedule in the short run.
- Pregnant or breast-feeding female.
- Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GFH009
all patients will be administrated with GFH009
|
patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase Ib: adverse events
Time Frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
|
Incidence of intolerable toxic events, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
|
From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
|
Phase II: Objective Response Rate
Time Frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
|
ORR(Objective Response Rate)
|
From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2023
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
June 28, 2023
First Submitted That Met QC Criteria
June 28, 2023
First Posted (Actual)
July 7, 2023
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFH009X1201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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Otsuka Pharmaceutical Co., Ltd.Active, not recruitingRelapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)Japan
-
AstraZenecaCompletedRelapsed/Refractory Peripheral T-cell Lymphoma | Relapsed/Refractory Classical Hodgkins LymphomaItaly, Sweden, United States, Taiwan, Korea, Republic of, United Kingdom, Australia, France, Singapore
-
Sun Yat-sen UniversityRecruitingRelapsed or Refractory Peripheral T-cell LymphomaChina
-
Dizal PharmaceuticalsCompletedRelapsed or Refractory Peripheral T Cell LymphomaKorea, Republic of, United States, China, Australia
-
Great Novel Therapeutics Biotech & Medicals CorporationRecruitingRelapsed or Refractory Peripheral T-cell LymphomaTaiwan
-
Kura Oncology, Inc.CompletedRelapsed or Refractory Peripheral T-Cell LymphomaUnited States, Spain, Korea, Republic of
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownRelapsed or Refractory Peripheral T-Cell LymphomaChina
-
Samsung Medical CenterCompletedRelapsed or Refractory Peripheral T-cell LymphomaKorea, Republic of
-
Mundipharma K.K.CompletedRecurrent or Refractory PTCLJapan
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownRelapsed or Refractory Peripheral T-cell and NK/T-cell LymphomaChina
Clinical Trials on GFH009
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Genfleet Therapeutics (Shanghai) Inc.Sellas Life Sciences GroupRecruitingHematologic MalignanciesChina, United States
-
Zhejiang Genfleet Therapeutics Co., Ltd.RecruitingLarge B-cell LymphomaChina