SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies

NCT06737081 | Recruiting Phase 2

• 1 other identifier: SAL0951B201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia

Keywords

Chemotherapy; Anemia; Enarodustat

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse events by CTCAE5.0

  laboratory abnormalities (based on whole blood count, biochemistry, coagulation function, fecal occult blood test and urinalysis tests), vital sign measurements (include blood pressure, pulse rate and body-temperature), physical examination-and-12-Lead electrocardiogram.

  through study completion, an average of 4 months

Secondary Outcomes (1)

• Change from baseline in mean Hb at the end of treatment (EOT);

  through study completion, an average of 4 months

Study Arms (2)

SAL-0951 tablets 4mg

EXPERIMENTAL

initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Drug: SAL-0951 tablets 4mg

SAL-0951 tablets 5mg

EXPERIMENTAL

initial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Drug: SAL-0951 tablets 5mg

Interventions

SAL-0951 tablets 4mg DRUG

initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Also known as: SAL-0951 tablets 4mg group

SAL-0951 tablets 4mg

SAL-0951 tablets 5mg DRUG

initial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Also known as: SAL-0951 tablets 5mg group

SAL-0951 tablets 5mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with body weight ≥40 kg at screening;
• Subjects 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 from the day of the first dose (Day 1);
• Subjects 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 the investigator;
• Subjects with ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% at screening;
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 at screening;
• Subjects with life expectancy ≥6 months as judged by the investigator on the date of first dose;
• All male subjects and female subjects 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 section 4.3 for acceptable method of contraception);
• Subjects 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.

You may not qualify if:

• Subjects with tumor who are receiving myelosuppressive chemotherapy and whose expected outcome is cured;
• Subjects 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, if chemotherapy is used in combination with these drugs, subjects can be enrolled;
• Subjects 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, pegmolesatide) within 4 weeks before the first dose of investigational product;
• Subjects 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 can be included if ALT/AST is within the normal limit and the investigator believes that there is no safety concern)
• With estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73 m2 based on CKD-EPI 2009scr formula, as shown in Appendix 3.
• Subjects 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 \>100 mmHg despite antihypertensive medication), or hypertensive crisis or hypertensive encephalopathy, or a history of significant valvular or endocardial disease that would put them at risk for thromboembolism within 6 months prior to screening and/or within the screening period;
• Subjects 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 (excluding asymptomatic lacunar infarction);
• Subjects 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 thalassemia, anemia caused by severe infection (such as active pulmonary tuberculosis, fungal infection, etc.) or existing active bleeding lesions (such as lung cancer-related hemoptysis, gastrointestinal tumor bleeding, gastrointestinal ulcer bleeding, etc.);
• Subjects with active systemic infection requiring chronic antibiotic therapy;
• Subjects with clinically significant or uncontrolled ongoing inflammatory/autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, celiac disease, etc.);
• Subjects with need for an ophthalmological procedure due to diabetic eye disease, diabetic macular edema or age-related macular degeneration, or subjects with proliferative choroidal or retinal lesions;
• Subjects 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 gastrectomy;
• Subjects known to have polycystic kidney disease;
• Subjects 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 HBV-DNA \>20 IU/mL), chronic hepatitis C (positive for hepatitis C antibody, and HCV-RNA quantitative detection higher than the upper limit of normal), autoimmune hepatitis, cirrhosis, or acute liver failure;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Anemia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Shun Lu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhou, MD

CONTACT

021-22200000; Jenniferzhou1116@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 17, 2024
• Study Start: September 14, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)