RecruitingPhase I/IIEN original

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18 lat lub więcej (dla niektórych grup także dzieci od 12 lat i starsze)
  • Rozpoznana białaczka (AML) lub chłoniak, które nie odpowiadają na poprzednie leczenie
  • Podpisana zgoda na udział w badaniu
  • Prawidłowe funkcjonowanie wątroby (test krwi)
  • Prawidłowe funkcjonowanie nerek (test krwi)
  • Ogólny stan zdrowia pozwalający na leczenie (ocena lekarza)
  • Stabilne poziomy elektrolitów i kwasu moczowego przez co najmniej 3 dni przed rozpoczęciem leczenia
  • Liczba białych krwinek poniżej 50 000/µL

Simplified criteria — AI translation

Trial details

Minimum age
12 Years
Last updated (source)
July 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (26)

O'Neal Comprehensive Cancer Center, University of Alabama

Birmingham, United States

City of Hope - Phoenix

Goodyear, United States

City of Hope National Medical Center

Duarte, United States

Moffitt Cancer Center

Tampa, United States

City of Hope - Atlanta

Newnan, United States

City of Hope - Chicago

Zion, United States

Ochsner Clinic Foundation

New Orleans, United States

Clinical Research Alliance, Inc.

Lake Success, United States

New York - Presbyterian Hospital

New York, United States

UNC School of Medicine, Division of Hematology

Chapel Hill, United States

Bon Secours St. Francis Cancer Center

Greenville, United States

Baylor Scott & White Health

Dallas, United States

MD Anderson

Houston, United States

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Anhui Provincial Hospital

Hefei, China

Affiliated Cancer Hospital of Chongqing University

Chongqing, China

Cancer prevention and treatment center of Sun Yat sen University

Guangzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

Affiliated Hospital of Hebei University

Baoding, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Soochow University

Suzhou, China

The First Affiliated Hospital Of Nanchang University

Nanchang, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, China

Linyi Cancer Hospital

Linyi, China

Blood disease hospital, Chinese Academy of Medical Science

Tianjin, China

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.

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