Cancer-Related AnemiaPhase 2NCT06075043
A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy
A Phase 2 study testing AND017 in people with Cancer-Related Anemia, run by Kind Pharmaceuticals LLC.
Trial summary
The purpose of this study is to determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-Related Anemia
- What is being tested?
- AND017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to Aug 2028
- 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
None listed.
Who cannot join
- Received chemotherapy, radiotherapy, and other, e.g., immunosuppressive, targeted drug therapy that has a suppressive effect on the bone marrow within 1 month prior to randomization or planned during the trial.
- A medical history of significant liver disease or active liver disease.
- A previous history of pure red blood cell remittance
- A combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active bleeding (three consecutive positive fecal occult bloods or clinical judgment of the investigator), hemolysis and other conditions that can cause anemia such as iron, folic acid or vitamin B12 deficiency
- Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)
- Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.).
Show all 13Show fewer
- clinically significant bleeding (including the need for blood transfusion or a drop in hemoglobin ≥ 2 g/dL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected
- uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values > 90 mmHg and/or systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing)
- concurrent congestive heart failure (New York Heart Association [NYHA] class III or higher)
- clinically significant ECG abnormalities at screening assessment.
- Have been treated with any hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to randomization
- have received treatment with an erythropoietic agent, androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 6 weeks prior to screening assessment.
- a history of significant medical or major surgical procedure within 3 months prior to the screening assessment or elective surgery planned during the conduct of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Anemia of Cancer in Patients Not Receiving Chemotherapy
The purpose of this study is to determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
- Conditions
- Cancer-Related Anemia
- Being tested
- AND017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AND017Drug
Oral administration of AND017 capsules three times per week
| Study group | Role | What they receive |
|---|---|---|
| AND017 Dose A three times weekly | Experimental | Not described Receives: Drug: AND017 |
| AND017 Dose B three times weekly | Experimental | Not described Receives: Drug: AND017 |
| AND017 Dose C three times weekly | Experimental | Not described Receives: Drug: AND017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responding patients
Responding patient is defined as those with a maximum elevated hemoglobin level greater than 10% of baseline from baseline to five weeks after dosing.
Measured: From Baseline to Week 6 or End of Treatment visit
Secondary outcomes (5)
Transfusion treatment rate
The percentage of subjects who need to receive blood transfusion during the trial
Measured: From Baseline to Week 6 or End of Treatment visit
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Measured: From Baseline to Week 6 or End of Treatment visit
Percentage of visits in which subjects maintained a hemoglobin elevation between >10% and 12.0 g/dL above baseline after reaching 10% of baseline
Percentage of visits in which subjects maintained a hemoglobin elevation between >10% and 12.0 g/dL above baseline after reaching 10% of baseline
Measured: From Baseline to Week 6 or at End of Treatment visit
Percentage of patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment
Percentage of patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment
Measured: From Baseline to Week 6 or at End of Treatment visit
Percentage of subjects requiring blood transfusions during the trial
Percentage of subjects requiring blood transfusions during the trial
Measured: From Baseline to Week 6 or at End of Treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startDec 2027 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-Related AnemiaStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kind Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusha Zhu, MD, PhD, Study director, Kind Pharmaceuticals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075043
- Sponsor's protocol ID
- AND017-CRA-204
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2023
- Last updated
- 1 Sep 2026
- Results posted
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Anemia of Cancer in Patients Not Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06075043
- Acronym / sponsor ID
- AND017-CRA-204
- Conditions
- Cancer-Related Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kind Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2027 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 10 Oct 2023 (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 determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AND017 Dose A three times weekly | Experimental | Drug: AND017 |
| AND017 Dose B three times weekly | Experimental | Drug: AND017 |
| AND017 Dose C three times weekly | Experimental | Drug: AND017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Received chemotherapy, radiotherapy, and other, e.g., immunosuppressive, targeted drug therapy that has a suppressive effect on the bone marrow within 1 month prior to randomization or planned during the trial.
- A medical history of significant liver disease or active liver disease.
- A previous history of pure red blood cell remittance
- A combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active bleeding (three consecutive positive fecal occult bloods or clinical judgment of the investigator), hemolysis and other conditions that can cause anemia such as iron, folic acid or vitamin B12 deficiency
- Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)
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 |
|---|---|---|
| AND017Oral administration of AND017 capsules three times per week | Drug | AND017 Dose A three times weekly, AND017 Dose B three times weekly, AND017 Dose C three times weekly |
Primary outcome
Percentage of responding patients
Time frame: From Baseline to Week 6 or End of Treatment visit
Responding patient is defined as those with a maximum elevated hemoglobin level greater than 10% of baseline from baseline to five weeks after dosing.
5 secondary outcomes
Transfusion treatment rate
Time frame: From Baseline to Week 6 or End of Treatment visit
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Time frame: From Baseline to Week 6 or End of Treatment visit
Percentage of visits in which subjects maintained a hemoglobin elevation between >10% and 12.0 g/dL above baseline after reaching 10% of baseline
Time frame: From Baseline to Week 6 or at End of Treatment visit
Percentage of patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment
Time frame: From Baseline to Week 6 or at End of Treatment visit
Percentage of subjects requiring blood transfusions during the trial
Time frame: From Baseline to Week 6 or at End of Treatment visit
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 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer-Related Anemia
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia
Fanconi Anemia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Not yet recruitingPhase 2
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
Chemotherapy Induced Anemia
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.
Yusha Zhu, MD, PhD study director
Kind Pharmaceuticals LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AND017 in people with Cancer-Related Anemia, run by Kind Pharmaceuticals LLC.
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 0 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yusha Zhu, MD, PhD (6467252552, yushazhu@kindpharmaceutical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of responding patients (time frame: From Baseline to Week 6 or End of Treatment visit). 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 1 Sep 2026.