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New treatment option for Anemia
Official title SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
ClinicalTrials.gov ID: NCT06737081
What this study is testing
What is SAL-0951 tablets 4mg?
SAL-0951 tablets 4mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anemia.
Also referred to as SAL-0951 tablets 4mg group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with body weight ≥40 kg at screening;
- people with histologically or cytologically confirmed diagnosis of non-myeloid malignancy (non-curative), and planned to receive anti-tumor treatment...
- people with myelosuppressive chemotherapy-related anemia, defined as central laboratory Hb ≤100 g/L during the screening period, and documented...
- people with ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% at screening;
- people with Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 at screening;
You likely can't join if
- people with tumor who are receiving myelosuppressive chemotherapy and whose expected outcome is cured;
- people who receive hormonal agents, biologics, novel immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors) or targeted biologic...
- people who have received blood transfusion therapy containing red blood cells or ESAs (including but not limited to recombinant human erythropoietin...
- people with abnormal hepatic or renal function test results at screening as follows:
- Patients with alanine transaminase (ALT) \>3×upper limit of normal (ULN), or aspartate transaminase (AST) \>3×ULN, or total bilirubin (TBL) \>1.5×ULN...
- With estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73 m2 based on CKD-EPI 2009scr formula, as shown in Appendix 3.
See the full eligibility criteria
Who can join
- people with body weight ≥40 kg at screening;
- people with histologically or cytologically confirmed diagnosis of non-myeloid malignancy (non-curative), and planned to receive anti-tumor treatment (myelosuppressive chemotherapy) for at least 6 weeks simultaneously...
- people with myelosuppressive chemotherapy-related anemia, defined as central laboratory Hb ≤100 g/L during the screening period, and documented decrease in Hb level ≥10 g/L after the start of chemotherapy as judged by...
- people with ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% at screening;
- people with Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 at screening;
- people with life expectancy ≥6 months as judged by the investigator on the date of first dose;
- All male people and female people of childbearing potential who agree to use a medically acceptable method of contraception from the day of signing the ICF until 90 days after last dose of investigational product (see...
- people voluntary to participate in the trial, having signed the ICF, able to understand the procedures and methods of this trial and willing to strictly follow the clinical trial protocol to complete the trial.
What rules you out
- people with tumor who are receiving myelosuppressive chemotherapy and whose expected outcome is cured;
- people who receive hormonal agents, biologics, novel immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors) or targeted biologic therapy or radiation therapy alone to treat/control their tumors. However...
- people who have received blood transfusion therapy containing red blood cells or ESAs (including but not limited to recombinant human erythropoietin, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta/CERA...
- people with abnormal hepatic or renal function test results at screening as follows:
- Patients with alanine transaminase (ALT) \>3×upper limit of normal (ULN), or aspartate transaminase (AST) \>3×ULN, or total bilirubin (TBL) \>1.5×ULN are not allowed to be enrolled in the study (those with TBL ≤2×ULN...
- With estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73 m2 based on CKD-EPI 2009scr formula, as shown in Appendix 3.
- people with congestive heart failure (New York Heart Association [NYHA] Class III or greater), unstable angina, uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure...
- people with thromboembolic events (including but not limited to deep vein thrombosis [DVT], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack [TIA]) within 6 months prior to screening...
- people with clinically significant anemia caused by other causes, such as macrocytic anemia caused by vitamin B12 or folic acid deficiency, autoimmune anemia, hemolysis, genetic anemia such as sickle cell anemia or...
- people with active systemic infection requiring chronic antibiotic therapy;
- people with clinically significant or uncontrolled ongoing inflammatory/autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, celiac disease, etc.);
- people with need for an ophthalmological procedure due to diabetic eye disease, diabetic macular edema or age-related macular degeneration, or people with proliferative choroidal or retinal lesions;
- people known to have significant gastrointestinal abnormalities, which would affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total...
- people known to have polycystic kidney disease;
- people known to have serious liver disease or active liver disease (except non-alcoholic hepatic steatosis), including chronic hepatitis B (positive for hepatitis B surface antigen or hepatitis B core antibody, and...
- people tested positive for human immunodeficiency virus (HIV) antibody;
- people with major surgery anticipated to occur during the trial;
- people with myeloid malignancies (such as chronic myeloid leukemia, etc.);
- people with primary or metastatic malignant tumors of the central nervous system;
- people with anticipated use of dapsone during the trial;
- people with hypersensitivity to HIF-PH inhibitors or any of the product components;
- people with a history of drug or alcohol abuse in the past two years\ ; \ An average of 14 units of alcohol per week (1 unit ≈ 360 mL of beer, or 45 mL of liquor, or 150 mL of wine) in 2 years before screening.
- people who have received another investigational product (or study drug), have received treatment with an investigational device (or study device), or have participated in clinical research involving intervention...
- people who have participated in clinical trials of HIF-PH inhibitor treatment (including enarodustat) within 4 weeks before screening and have received investigational product (active drug) treatment;
- people who are pregnant, lactating, or may be pregnant (the possibility of pregnancy cannot be ruled out by the investigator based on the results of pregnancy test at screening visit);
- people who have taken traditional Chinese medicine, Chinese patent medicine, and/or herbal medicine for anemia within 2 weeks before the first dose of investigational product;
- people with any other medical condition that, in the opinion of the investigator, could pose a safety risk to them in this trial, could confound how well it works or safety assessment, or could interfere with their...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.