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NCT04588922 · ClinicalTrials.gov registry record · Phase 1
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 study of Hematologic Malignancies, sponsored by Sellas Life Sciences Group.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04588922: Recruiting Phase 1 study of Hematologic Malignancies, sponsored by Sellas Life Sciences Group.
NCT04588922 is a Phase 1 study of Hematologic Malignancies that is actively recruiting participants, run by Sellas Life Sciences Group. The registered enrollment target is 160 participants, below the 2,708-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04588922, a Phase 1 study of Hematologic Malignancies, is actively recruiting participants, sponsored by Sellas Life Sciences Group.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study 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). 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.
Primary Outcome
The incidence of DLTs
Conditions Studied
Interventions
- DRUG SLS009
- DRUG venetoclax
- DRUG azacitidine
Study Locations (20)
New York
- Clinical Research Alliance, Inc. - Lake Success
- New York - Presbyterian Hospital - New York
Texas
- Baylor Scott & White Health - Dallas
- MD Anderson - Houston
Anhui
- The First Affiliated Hospital of Bengbu Medical College - Bengbu
- Anhui Provincial Hospital - Hefei
Guangdong
- Cancer prevention and treatment center of Sun Yat sen University - Guangzhou
- Guangdong Provincial People's Hospital - Guangzhou
Alabama
- O'Neal Comprehensive Cancer Center, University of Alabama - Birmingham
Louisiana
- Ochsner Clinic Foundation - New Orleans
North Carolina
- UNC School of Medicine, Division of Hematology - Chapel Hill
South Carolina
- Bon Secours St. Francis Cancer Center - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04588922 shows while recruiting
NCT04588922 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 2,708-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 3 interventions - of which SLS009 is the first listed.
NCT04588922 names 20 study sites across 16 states, led by New York, Texas, Anhui.
Frequently Asked Questions
What is clinical trial NCT04588922 about?
NCT04588922 is a clinical study titled "Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With 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 ly...
What is the current status of trial NCT04588922?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2021-05-10. Estimated completion is 2027-12-31.
What conditions does trial NCT04588922 study?
This clinical trial studies the following conditions: Hematologic Malignancies.
What interventions are being tested in trial NCT04588922?
The interventions under investigation include: SLS009 (DRUG), venetoclax (DRUG), azacitidine (DRUG).
Who is sponsoring clinical trial NCT04588922?
This trial is sponsored by Sellas Life Sciences Group, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04588922 being conducted?
This trial has 20 study locations across Alabama, Louisiana, New York, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04588922's enrollment target sits among peer trials
160 11th of 45 higher than 35 of 45 other Hematologic Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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