AnemiaPhase 2NCT06737081
SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
A Phase 2 study testing SAL-0951 tablets 4mg and SAL-0951 tablets 5mg in people with Anemia, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- SAL-0951 tablets 4mg and SAL-0951 tablets 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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;
- Subjects tested positive for human immunodeficiency virus (HIV) antibody;
- Subjects with major surgery anticipated to occur during the trial;
- Subjects with myeloid malignancies (such as chronic myeloid leukemia, etc.);
- Subjects with primary or metastatic malignant tumors of the central nervous system;
- Subjects with anticipated use of dapsone during the trial;
- Subjects with hypersensitivity to HIF-PH inhibitors or any of the product components;
- Subjects 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.
- Subjects 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 (medical action beyond the scope of ordinary medical practice) and received treatment during the period within 8 weeks prior to the screening;
- Subjects 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;
- Subjects 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);
- Subjects 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;
- Subjects with any other medical condition that, in the opinion of the investigator, could pose a safety risk to them in this trial, could confound efficacy or safety assessment, or could interfere with their participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, MD
Jian Zhou, MD
About this study
Official title: A Parallel, Open-label Phase II Clinical Study of Enarodustat (SAL-0951) Tablets in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
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
Read the detailed description
This trial is a multicenter, randomized, open-label phase II clinical study exploring the starting dose, aiming to evaluate the safety and efficacy of Enarodustat Tablets in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies, so as to optimize the dose for phase III trials. It is planned to enroll approximately 60 patients.
The trial consists of a screening period (4 weeks), an open-label treatment period (up to 16 weeks), and a follow-up period (2 weeks), totaling approximately 22 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.
- Conditions
- Anemia
- Being tested
- SAL-0951 tablets 4mg, SAL-0951 tablets 5mg
- Keywords
- Chemotherapy, Anemia, Enarodustat
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL-0951 tablets 4mgDrug
Also called SAL-0951 tablets 4mg group
initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
SAL-0951 tablets 5mgDrug
Also called SAL-0951 tablets 5mg group
initial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: SAL-0951 tablets 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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, the change from baseline in mean Hb at the end of treatment
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start14 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737081
- Sponsor's protocol ID
- SAL0951B201
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Open-label Phase II Clinical Study of Enarodustat (SAL-0951) Tablets in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
- ClinicalTrials.gov ID
- NCT06737081
- Acronym / sponsor ID
- SAL0951B201
- Conditions
- Anemia
- Keywords
- Chemotherapy, Anemia, Enarodustat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This trial is a multicenter, randomized, open-label phase II clinical study exploring the starting dose, aiming to evaluate the safety and efficacy of Enarodustat Tablets in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies, so as to optimize the dose for phase III trials. It is planned to enroll approximately 60 patients.
The trial consists of a screening period (4 weeks), an open-label treatment period (up to 16 weeks), and a follow-up period (2 weeks), totaling approximately 22 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAL-0951 tablets 4mg | Experimental | Drug: SAL-0951 tablets 4mginitial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks |
| SAL-0951 tablets 5mg | Experimental | Drug: SAL-0951 tablets 5mginitial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (28 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAL-0951 tablets 4mgAlso: SAL-0951 tablets 4mg groupinitial 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 5mgAlso: SAL-0951 tablets 5mg groupinitial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks | Drug | SAL-0951 tablets 5mg |
Primary outcome
Incidence of Adverse events by CTCAE5.0
Time frame: through study completion, an average of 4 months
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.
1 secondary outcome
Change from baseline in mean Hb at the end of treatment (EOT);
Time frame: through study completion, an average of 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shun Lu, MD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAL-0951 tablets 4mg and SAL-0951 tablets 5mg in people with Anemia, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhou, MD (021-22200000, Jenniferzhou1116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events by CTCAE5.0 (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.