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CDK9 inhibitor
GFH009 for Blood Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Genfleet Therapeutics (Shanghai) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 × ULN
Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL/SLL and lymphoma)
Must not have
History of HIV infection or HIV positive at screening
Patients with bulky disease (≥ 10 cm) who require cytoreductive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug to treat cancer, and will explore its safety and effectiveness.
Who is the study for?
This trial is for adults with certain blood cancers like AML, CLL/SLL, and lymphoma that have come back or didn't respond to treatment. They must have normal levels of bilirubin (unless they have Gilbert's syndrome), liver enzymes, amylase, lipase, and stable electrolytes. Women who can get pregnant and men with partners who can get pregnant must use two effective birth control methods during the study.
What is being tested?
The trial tests GFH009 alone in patients with relapsed/refractory acute myeloid leukemia (AML) or lymphomas. It also tests GFH009 combined with venetoclax and azacitidine in AML patients resistant to venetoclax-based treatments. The goal is to see how safe it is and if it helps against these cancers.
What are the potential side effects?
Possible side effects include reactions related to liver function changes, digestive enzyme alterations, potential heart issues due to QT interval prolongation on ECGs (a type of heart rhythm problem), as well as general risks associated with cancer drugs such as fatigue or increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within the required limits.
Select...
My cancer, such as AML, CLL/SLL, or lymphoma, has returned or is not responding to treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am HIV positive.
Select...
I have a large tumor (10 cm or larger) that needs treatment to reduce its size.
Select...
I have had a heart attack or other serious heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability: Dose Limiting Toxicities (DLTs)
Safety and Tolerability: adverse events (AEs)
Secondary study objectives
Efficacy: DOR
Efficacy: ORR
Efficacy: PFS
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutationsExperimental Treatment3 Interventions
SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification.
Group II: Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation.Experimental Treatment3 Interventions
SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented ASXL1 mutation.
Group III: Group 3 Cohort 3. 30 mg BIW in patients with r/r AML.Experimental Treatment3 Interventions
SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed).
Group IV: Group 3 Cohort 2. 60 mg QW in patients with r/r AML.Experimental Treatment3 Interventions
SLS009 (60 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed).
Group V: Group 3 Cohort 1. 45 mg QW in patients with r/r AMLExperimental Treatment3 Interventions
SLS009 (45 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed)
Group VI: Group 2. Dose escalation in patients with r/r CLL/SLL or lymphomaExperimental Treatment1 Intervention
In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China and US study sites. (Completed).
Group VII: Group 1. Dose escalation in patients with r/r AMLExperimental Treatment1 Intervention
In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China study sites only. (Completed).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venetoclax
2014
Completed Phase 2
~740
azacitidine
2005
Completed Phase 3
~1730
Find a Location
Who is running the clinical trial?
Genfleet Therapeutics (Shanghai) Inc.Lead Sponsor
6 Previous Clinical Trials
694 Total Patients Enrolled
Zhejiang Genfleet Therapeutics Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
744 Total Patients Enrolled
Sellas Life Sciences GroupLead Sponsor
8 Previous Clinical Trials
612 Total Patients Enrolled
Alan Zhu at GenFleetStudy DirectorStudy Chair
Dragan Cicic, MDStudy ChairSELLAS Life Sciences Group, Inc.
Alan ZhuStudy ChairGenFleet Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.My liver enzymes are within the required limits.I have a large tumor (10 cm or larger) that needs treatment to reduce its size.I have had a heart attack or other serious heart problems.I have stable brain metastases and haven't needed more steroids for at least 4 weeks.I haven't had serious heart problems in the last 6 months.I haven't had any cancer except for certain skin, cervical, prostate, breast, or superficial bladder cancers in the last 5 years.I am not on medications that affect heart rhythm, except for antifungal meds if I have AML.I agree to use two effective birth control methods during and 90 days after treatment.My electrolyte and uric acid levels have been stable for at least 3 days.I haven't taken strong medication or consumed certain citrus fruits and St. John's wort in the last week.My cancer, such as AML, CLL/SLL, or lymphoma, has returned or is not responding to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2. Dose escalation in patients with r/r CLL/SLL or lymphoma
- Group 2: Group 1. Dose escalation in patients with r/r AML
- Group 3: Group 3 Cohort 1. 45 mg QW in patients with r/r AML
- Group 4: Group 3 Cohort 2. 60 mg QW in patients with r/r AML.
- Group 5: Group 3 Cohort 3. 30 mg BIW in patients with r/r AML.
- Group 6: Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation.
- Group 7: Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.