Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML

Recruiting now · Phase 1/Phase 2

Conditions studied: Hematologic Malignancies

In brief

SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.

Key facts

Study ID: NCT04588922
Run by: Sellas Life Sciences Group
People needed: 160
Starts: 2021-05-10
Expected to finish: 2027-12-31
Last updated by the study team: 2026-07-29

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For Groups 1, 2, 3, 4 and 5:
Patients eligible for inclusion must meet all of the following criteria:
Male or female ≥ 18 years. For Group 3 Cohorts 4 and 5 only male or female ≥18 years and pediatric patients 12-18 years and ≥40 kg body mass
Written informed consent must be obtained prior to any screening procedures
For AML, acute promyelocytic leukemia (APL) patients are not included in the study.
Adequate hepatic function as evidenced by meeting all the following requirements:
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.
Measured or calculated (determined by the Cockcroft-Gault equation) serum creatinine clearance (CrCl) ≥ 60 mL/min (glomerular filtration rate can be alternative to CrCl) for adult patients or serum creatinine ≤ 1.5 x ULN; or if serum creatinine > 1.5 x ULN, then serum creatinine clearance (CrCl) ≥ 50 mL/min (estimated by Cockcroft-Gault formula or other appropriate formula) for pediatric patients. Whether the value is calculated by equation or measured directly can be based on institutional standard practice.
Amylase ≤ 1.5 × ULN.
Eastern cooperative oncology group (ECOG) performance status 0-2.
The electrolytes and uric acid level need to be stable judged by investigators for at least 3 days before the first dose of GFH009 (Medical intervention is permitted).
For AML and other leukemias:
Peripheral WBC counts < 50,000/µL. Cytoreduction prior to study will be allowed with hydroxyurea; hydroxyurea use will also be permitted during treatment period in patients with proliferative, progressive disease. Use of leukapheresis for the purpose of lowering WBC counts to make the patient eligible for enrolment is not permitted.
Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue, < Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy.
For women of childbearing potential, she must consent to use highly effective methods (e.g., 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 if enrolled in Group 1 and 2, and 6 months enrolled in Group 3.
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.
For Groups 1, 2 and 3:
Patients eligible for inclusion must meet all of the following criteria:
Male or female ≥ 18 years. Pediatric patients ages 12-18 and ≥40 kg body mass.
Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL/SLL and lymphoma):
For Lymphoma, Burkitt lymphoma, lymphoblastic lymphoma, cutaneous T-Cell lymphoma and lymphoplasmacytic lymphoma (LPL)/ Waldenstrom's macroglobulinemia (WM) will be excluded.
Patients must not be candidates for hematopoietic cell transplant (HCT) at the time of screening.
AML (only for Group 3): Patients relapsed on or refractory to venetoclax containing regimens.
Additional requirements for specific disease conditions are:

You may not qualify if…

For Groups 1, 2, 3, 4 and 5:
Patients eligible for inclusion must not meet any of the following criteria:
Uncontrolled medical conditions such as hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg), a history of hypertensive crisis, or a history of hypertensive encephalopathy.
History of previous exposure to any other CDK9 inhibitors.
Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.
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), left ventricular ejection fraction (LVEF) < 50% as determined by MUGA scan or echocardiogram (ECHO), (if only with historical occasional low LVEF but without any symptoms or relevant medical history, and the LVEF at screening is > 50%, 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).
Average QTcF ≥ 450 msec (males) or ≥ 470 msec (females) on screening ECG.
Moderate or above regurgitation on echocardiogram
Patients with prior treatment with cardiotoxic agents who have experienced drug induced cardiotoxicities during or after treatment, where cardiotoxic agents include but are not limited to anthracyclines (doxorubicin, daunorubicin, epirubicin, idarubicin, mitoxantrone); trastuzumab and trastuzumab based ADCs; tyrosine kinase inhibitors (sunitinib, imatinib); alkylating agents (cyclophosphamide).
Patients who are on systemic antibiotics are eligible to participate as long as the antibiotics are not expected to have significant DDI with GFH009 (A list of approved concomitant medications will be provided to investigators. If any antibiotic is not included in the approved list, it can be discussed with the sponsor or designated CRO on a case-by-case basis).
Active hepatitis B or hepatitis C virus infection. Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy have to be on a suppressive antiviral therapy prior to enrollment.
Patients with HCV may be enrolled if the HCV is stable, and the patient is not at risk for hepatic decompensation.
Patients with known HIV infection except if:
They have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL, and
No history of AIDS-defining opportunistic infections within the last 12 months preceding screening, and
Are on established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
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.
Stroke or intracranial hemorrhage within 6 months.
Major surgery within 4 weeks prior to study entry.
Pregnant or breast-feeding females.
Prior allogeneic stem cell transplant within 6 months of study entry. Patients who received autologous HCT, if considered to be enrolled and must be > 3 months post-transplant and meet hematologic inclusion criteria.
Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.
Medications that are known to prolong the QT interval that could not be stopped prior to study entry judged by investigator, except azole antifungal medications in AML patients.

Where it is running

City of Hope National Medical Center — Duarte, California, United States (enrolling)
Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
UNC School of Medicine, Division of Hematology — Chapel Hill, North Carolina, United States (enrolling)
Bon Secours St. Francis Cancer Center — Greenville, South Carolina, United States (enrolling)
Baylor Scott & White Health — Dallas, Texas, United States (enrolling)
MD Anderson — Houston, Texas, United States (enrolling)
City of Hope - Atlanta — Newnan, Georgia, United States (enrolling)
City of Hope - Chicago — Zion, Illinois, United States (enrolling)
City of Hope - Phoenix — Goodyear, Arizona, United States (enrolling)
O'Neal Comprehensive Cancer Center, University of Alabama — Birmingham, Alabama, United States (enrolling)
Henan Cancer Hospital — Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
The First Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China
Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning, China
Linyi Cancer Hospital — Linyi, Shandong, China
Blood disease hospital, Chinese Academy of Medical Science — Tianjin, Tianjin Municipality, China
The Second Affiliated hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Ochsner Clinic Foundation — New Orleans, Louisiana, United States
Clinical Research Alliance, Inc. — Lake Success, New York, United States
New York - Presbyterian Hospital — New York, New York, United States
The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China
Anhui Provincial Hospital — Hefei, Anhui, China
Affiliated Cancer Hospital of Chongqing University — Chongqing, Chongqing Municipality, China
Cancer prevention and treatment center of Sun Yat sen University — Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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