Hematologic MalignanciesPhase 1/2NCT04588922
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
A Phase 1/2 study testing SLS009, venetoclax and azacitidine in people with Hematologic Malignancies, run by Sellas Life Sciences Group at 32 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- SLS009, venetoclax and azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 10 May 2021to 31 Dec 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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:
- CLL/SLL: Peripheral blood lymphocytosis (with no other cause), CLL present on BM aspirate, or enlarged lymph node (LN), liver or spleen.
- Lymphoma (Except for other leukemias): At least one measurable or evaluable lesion as defined by the Lugano (2014) response criteria. Patients must have received at least 2 prior lines of systemic therapy.
- AML, Cohort 4 (ASXL1 mutations): AML patients relapsed on and/or refractory to therapies containing venetoclax combinations and with documented ASXL1 mutation.
- AML, Cohort 5 (Other than ASXL1 Myelodysplasia related AML defining somatic mutations): AML patients relapsed on and/or refractory to therapies containing venetoclax combinations and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification.
- Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.If any of those mutations is present concurrently with ASXL1 mutation, patients will be enrolled in Cohort 4 (ASXL1 mutation) and only patients harboring the above listed mutations without concurrent ASXL1 mutation will be enrolled in Cohort 5 (Other than ASXL1 Myelodysplasia related AML defining somatic mutations).
- Life expectancy ≥ 12 weeks.
- The following hematological clinical laboratory results during screening:
- For lymphoma, CLL/SLL patients:
- Absolute neutrophil count: for lymphoma ≥ 1,000/µL without growth factor support in the 2 weeks prior to study entry; for CLL/SLL, ANC must be ≥ 500/µL if myelosuppression is known to be due to BM involvement with leukemia.
- Hemoglobin ≥ 7.5 g/ dL without transfusion or erythropoietin treatment in the 2 weeks prior to study entry. Patients with BM involvement will not have the threshold of hemoglobin at screening.
- Platelet count ≥ 50,000/µL without transfusion or other interventions in the 2 weeks prior to study entry.
- For Groups 4 and 5:
- Patients eligible for inclusion must meet all of the following criteria:
- For Group 4: newly diagnosed AML patients who must meet 1 or more of the following 3 criteria:
- AML patients with AML MR (AML myelodysplasia related) as defined by WHO 5th Edition (The 5th edition of the World Health Organization Classification of Hematolymphoid Tumors: Myeloid and Histiocytic/Dendritic Neoplasms). Mutations include: ASXL1, BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1, and ZRSR2. Cytogenetic changes include: complex karyotype, 5q deletion or loss of 5q due to unbalanced translocation, monosomy 7, 7q deletion, or loss of 7q due to unbalanced translocation, 11q deletion, 12p deletion or loss of 12p due to unbalanced translocation, monosomy 13 or 13q deletion, 17p deletion or loss of 17p due to unbalanced translocation, isochromosome 17q, idic(X)(q13)); and/or
- AML MM (AML with myelomonocytic/ myelomonoblastic differentiation per FAB M4/M5) and/or
- Mayo 2024 HR/VHR (Mayo Genetic Risk Models for Newly Diagnosed Acute Myeloid Leukemia Treated With Venetoclax + Hypomethylating Agent. High Risk is defined as ≥2 points where points are: ELN 2022 Adverse Karyotype: 1 point; IDH2wt: 1 point; TP53mut: 1 point; KRASmut: 1 point; KMT2A rearrangement: 2 points).
- Group 5: First-line AML patients who have failed to achieve CR, CRi, or MLFS after the first 2 cycles of azacitidine/venetoclax (defined as ≥5% blasts in bone marrow or presence of circulating blasts after 2 cycles of azacitidine and venetoclax).
- Life expectancy ≥6 weeks.
Who cannot join
- 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:
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- 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.
- For Groups 1, 2 and 3:
- Patients eligible for inclusion must not meet any of the following criteria:
- For AML and other leukemias: Systemic chemotherapy or demethylating agent therapy within 7 days, or targeted therapy within 7 days or 5 half-lives whichever is shorter, or immunotherapy within 4 weeks, or CAR-T therapy within 12 weeks before the first dose. If a patient is receiving high dose cytarabine, liposomal cytarabine, or standard dose cytarabine (100-200 mg/m2/day), the patient must be off the drug for at least 2 weeks or until the patient has recovered from toxic effects. Patients in Group 3 are allowed to have received venetoclax and/or hypomethylating agents (HMAs) prior to screening and will continue receiving venetoclax in combination with azacitidine throughout the duration of the trial. No washout from HMAs and/or venetoclax is required for this group.
- For lymphoma and CLL/SLL: Patients who have received chemotherapy or targeted therapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) or 5 half-lives whichever is shorter, or immunotherapy (e.g., CD20 monoclonal antibody, CD38 monoclonal antibody, PD1 or PD-L1 antibody) within 4 weeks, or CAR-T therapy within 12 weeks prior to starting study drug.
- Patients with bulky disease (≥ 10 cm) who require cytoreductive therapy.
- Radiotherapy with wide field radiation within 28 days or radiotherapy with a limited field of radiation for palliation within 7 days of the first dose.
- Symptomatic central nervous system (CNS) 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.
- Ongoing therapy with corticosteroids greater than 20 mg of prednisone or its equivalent per day. Inhaled and topical steroids are allowed.
- Patients with a baseline cardiac biomarker abnormality (CKMB/cTnI) will be excluded.
- Patients with hypereosinophilic syndrome defined as eosinophil counts in peripheral blood of ≥1,500/µ.
- Pulmonary embolism within 6 months before study entry. Patients with a history of other clinically venous or arterial thrombotic events that the investigator feels puts the patient at risk for participation in the study (based on overall status, medical history, or other factors) will be excluded.
- 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).
- For AML patients only: Given that GFH009 is a CYP3A4 substrate and the critical role of azole antifungals (commonly strong CYP3A4 inhibitors) in the treatment of patients with AML, if use of azole antifungals is necessary for the patients in AML groups, and if azoles cannot be substituted with alternative antifungal drugs (e.g., caspofungin, amphotericin B etc.), use of isavuconazole, the only azole antifungal that is a moderate CYP3A4 inhibitors and does not prolong QT interval, is recommended. Other azoles are allowed if deemed necessary by the investigator. If azoles are used, AML patients receiving azole antifungals will be subject to enhanced monitoring plan provided in section 6.5.2. PK of GFH009 will be compared in patients with coadministration of azole antifungals versus those without azole antifungals.
- Subjects with high risk of gastrointestinal hemorrhage, including but not limiting to active ulcer with fecal occult blood test ≥++; history of hematemesis or melena within 2 months prior first dose.
- For Groups 4 and 5:
- Patients eligible for inclusion must not meet any of the following criteria:
- For patients in Group 4, no prior anti-leukemic therapy is allowed, except for ATRA if used for suspected APL, or hydroxyurea or cytarabine if used emergently for emergent cytoreduction or disease stabilization (a maximum total cumulative dose of cytarabine 1 g).
- For patients in Group 5, no prior antileukemic therapy except venetoclax and azacitidine for exactly 2 cycles is allowed prior to screening. Patients will continue receiving venetoclax in combination with azacitidine throughout the duration of the trial. No washout from azacitidine and venetoclax is required.
- For AML Group 4: presence of favorable risk cytogenetic markers including: NPM1-mutations (with FLT3-ITDneg, NRASwt, KRASwt, TP53wt); IDH2-mutations (with FLT3-ITDneg, NRASwt, KRASwt, TP53wt); IDH1-mutations (with TP53wt); AML with DDX41-mutations is excluded.
- Patients with a history of clinically significant venous or arterial thrombotic events that the investigator feels puts the patient at risk for participation in the study (based on overall status, medical history, or other factors) will be excluded.
- Concurrent malignancy within 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).
- Concurrent malignancy within 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).
- Given that GFH009 is a CYP3A4 substrate and the critical role of azole antifungals (commonly strong CYP3A4 inhibitors) in the treatment of patients with AML, if use of azole antifungals is necessary for the patients in AML groups, and if azoles cannot be substituted with alternative antifungal drugs (e.g., caspofungin, amphotericin B etc.), use of isavuconazole, the only azole antifungal that is a moderate CYP3A4 inhibitors and does not prolong QT interval, is recommended. Other azoles are allowed if deemed necessary by the investigator.
Trial locations and contacts
32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 2 countries
United States19 sites, 16 recruiting
- Recruiting
O'Neal Comprehensive Cancer Center, University of Alabama
Birmingham, Alabama, 35233
Omer Jamy, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Philip Amrein, MD
- Recruiting
UNC School of Medicine, Division of Hematology
Chapel Hill, North Carolina, 27599
Joshua Zeidner, MD
- Recruiting
Baylor Scott & White Health
Dallas, Texas, 75246
William Christensen, MD
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Amanda Blackmon
- Recruiting
City of Hope - Phoenix
Goodyear, Arizona, 85338
Misam Ziwat
- Recruiting
Bon Secours St. Francis Cancer Center
Greenville, South Carolina, 29607
Sharif Khan, MD
- Recruiting
MD Anderson
Houston, Texas, 77091
Tapan Kadia, MD
- Not yet recruiting
Mayo Clinic
Jacksonville, Florida, 32224
- Terminated
Clinical Research Alliance, Inc.
Lake Success, New York, 11042
- Not yet recruiting
Atlantic Health
Morristown, New Jersey, 07960
Mohamad Cherry, MD
- Terminated
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
- Terminated
New York - Presbyterian Hospital
New York, New York, 10032
- Recruiting
City of Hope - Atlanta
Newnan, Georgia, 30265
Sabarish Ayyappan
- Not yet recruiting
Mayo Clinic
Phoenix, Arizona, 85054
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Honor Health
Scottsdale, Arizona, 85258
Abdullah Ladha, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Rory Shallis, MD
- Recruiting
City of Hope - Chicago
Zion, Illinois, 60099
Neil Dunavin
China13 sites
- Completed
Affiliated Hospital of Hebei University
Baoding, Hebei
- Completed
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
- Withdrawn
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality
- Completed
Cancer prevention and treatment center of Sun Yat sen University
Guangzhou, Guangdong
- Completed
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
- Completed
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
- Completed
Anhui Provincial Hospital
Hefei, Anhui
- Completed
Linyi Cancer Hospital
Linyi, Shandong
- Completed
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
- Completed
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning
- Completed
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
- Completed
Blood disease hospital, Chinese Academy of Medical Science
Tianjin, Tianjin Municipality, 300000
- Completed
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies and High-Risk Newly Diagnosed AML
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.
Read the detailed description
SLS009 is a potent and highly selective CDK9 inhibitor. This study is investigating the safety, tolerability, and antitumor activity of SLS009 in patients with hematologic malignancies in three groups (two dose escalation groups and one expansion group). The safety and efficacy of SLS009 as a single agent are assessed in Group 1 (patients with relapsed/refractory AML) and Group 2 (patients with relapsed/refractory lymphoma/CLL/SLL). The safety and efficacy of SLS009 in combination with venetoclax and azacitidine in patients with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five different cohorts in the expansion Group 3. The cohorts in Group 3 include three cohorts to assess different dose levels (Cohorts 1, 2, and 3), a cohort enrolling patients with r/r AML and ASXL1 mutations (Cohort 4) and a cohort enrolling patients with r/r AML with other myelodysplasia-related mutations other than ASXL1 (Cohort 5). Group 4 (newly diagnosed AML with higher risk features by cytogenetic/morphology) and Group 5 (first-line AML patients who failed to achieve an object response after 2 cycles of azacitidine/venetoclax) have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine.
- Conditions
- Hematologic Malignancies
- Being tested
- SLS009, venetoclax, azacitidine
- Keywords
- Acute Myeloid Leukemia,, AML, Lymphoma, Chronic Lymphocytic Lymphoma, CLL, Small Lymphocytic Lymphoma, SLL, relapsed, refractory, CDK9 inhibitor, GFH009, SLS009, venetoclax, azacitidine, ASXL1
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Acute, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLS009Drug
Also called GFH009
Solution for injection
venetoclaxDrug
Also called Venclexta
Tablets
azacitidineDrug
Also called Vidaza, azacytidine
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Dose escalation in patients with r/r AML | Experimental | In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China study sites only. (Completed). Receives: Drug: SLS009 |
| Group 2. Dose escalation in patients with r/r CLL/SLL or lymphoma | Experimental | In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China and US study sites. (Completed). Receives: Drug: SLS009 |
| Group 3 Cohort 1. 45 mg QW in patients with r/r AML | Experimental | 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) Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 3 Cohort 2. 60 mg QW in patients with r/r AML. | Experimental | 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). Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 3 Cohort 3. 30 mg BIW in patients with r/r AML. | Experimental | 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). Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation. | Experimental | 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. Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations | Experimental | 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. Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 4 (treatment arm): SLS009, venetoclax, azacitidine | Experimental | SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with newly diagnosed AML less likely to benefit from standard venetoclax and azacitidine therapy based on molecular profiling. Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 4 (control arm): venetoclax and azacitidine | Active comparator | Venetoclax and azacitidine in patients with newly diagnosed AML less likely to benefit from standard venetoclax and azacitidine therapy based on molecular profiling. Receives: Drug: venetoclax; Drug: azacitidine |
| Group 5 (treatment arm): SLS009, venetoclax, azacitidine (not yet recruiting) | Experimental | SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with newly diagnosed AML. Patients who initiate treatment with venetoclax and azacitidine but demonstrate a confirmed lack of any response after two treatment cycles. Receives: Drug: SLS009; Drug: venetoclax; Drug: azacitidine |
| Group 5 (control arm): venetoclax and azacitidine (not yet recruiting) | Active comparator | Venetoclax and azacitidine in patients with newly diagnosed AML. Patients who initiate treatment with venetoclax and azacitidine but demonstrate a confirmed lack of any response after two treatment cycles. Receives: Drug: venetoclax; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Dose Limiting Toxicities (DLTs)
The incidence of DLTs
Measured: 21 to 28 days
Safety and Tolerability: adverse events (AEs)
The incidence and severity of all AEs
Measured: approximately 2 years
Efficacy: ORR
Overall response rate is the proportion of patients showing anti-leukemic activity in response to treatment
Measured: 2 years
Secondary outcomes (9)
PK parameter AUC0-t
Area under the plasma concentration-time curve (from zero to the time of the last measurable concentration)
Measured: approximately 3 months
PK parameter AUC0-∞
Area under the plasma concentration-time curve (from zero to infinity)
Measured: approximately 3 months
Efficacy: DOR
Duration of response in patients
Measured: 2 years
Efficacy: PFS
Progression-free survival
Measured: 2 years
Efficacy:OS
Overall survival
Measured: 2 years
PK parameter Cmax
Maximum plasma concentration reached following administration of study drug
Measured: approximately 3 months
PK parameter Tmax
Time for maximum plasma concentration reached following administration of study drug
Measured: approximately 3 months
PK parameter t½
Half-life of study drug
Measured: approximately 3 months
Efficacy: ORR
Overall response rate is the proportion of patients showing anti-leukemic activity in response to treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start10 May 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Open Label, Multi-center
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sellas Life Sciences Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dragan Cicic, MD, Study chair, SELLAS Life Sciences Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588922
- Sponsor's protocol ID
- GFH009X2101
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No