RecruitingPhase 1Phase 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 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

Sponsor

Sellas Life Sciences Group

Enrollment

160 participants

Start Date

May 10, 2021

Study Type

INTERVENTIONAL

Conditions

Hematologic Malignancies

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called SLS009 (also known as GFH009) for people with blood cancers such as leukemia and lymphoma, including a group for newly diagnosed high-risk acute myeloid leukemia (AML). The drug targets a protein called CDK9 that some cancer cells depend on to grow. **You may be eligible if...** - You are 18 or older (some groups allow ages 12–18 if weight is at least 40 kg) - You have a blood cancer such as AML, lymphoma, or a related condition - Your liver, kidney, and blood counts are within acceptable ranges - Your overall health/functional status is reasonably good (able to care for yourself) - Your white blood cell count is below a certain threshold before starting **You may NOT be eligible if...** - You have a type of AML called acute promyelocytic leukemia (APL) - Your liver or kidney function is significantly impaired - You have not recovered from side effects of prior cancer treatment - You are pregnant or breastfeeding - You have uncontrolled active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSLS009

Solution for injection

DRUGvenetoclax

Tablets

DRUGazacitidine

Solution for injection

Locations(25)

O'Neal Comprehensive Cancer Center, University of Alabama

Birmingham, Alabama, United States

City of Hope - Phoenix

Goodyear, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope - Atlanta

Newnan, Georgia, United States

City of Hope - Chicago

Zion, Illinois, United States

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

UNC School of Medicine, Division of Hematology

Chapel Hill, North Carolina, United States

Bon Secours St. Francis Cancer Center

Greenville, South Carolina, United States

Baylor Scott & White Health

Dallas, Texas, United States

MD Anderson

Houston, Texas, 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

Affiliated Hospital of Hebei University

Baoding, Hebei, China

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04588922

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