New pill aims to boost red blood cells in cancer patients
NCT ID NCT06075043
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This Phase 2 trial tests an oral drug called AND017 for anemia (low red blood cells) in cancer patients who are not receiving chemotherapy. The study will enroll 36 participants to see if different doses of AND017 can safely raise hemoglobin levels over 6 weeks. The goal is to reduce the need for blood transfusions and improve energy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AND017
- What this could lead to
- If successful, this could offer a new oral treatment option for anemia in cancer patients, potentially reducing the need for blood transfusions.
- What could go wrong
- This is an early Phase 2 trial with only 36 participants, so results may not apply broadly. The drug may not effectively raise hemoglobin or could have side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: 1. Non-myeloid malignancy diagnosed by cytology/histology. 2. ECOG score 0-2 and expected survival of 6 months or more. 3. The mean value of hemoglobin at screening test and one follow-up test (more than one week between tests) was \<10.0 g/dL, with a difference of ≤1.0 g/dL between the two tests. 4. Adequate hepatic and renal function. * Total bilirubin \< 1.5 x upper limit of normal (ULN). * Subjects with Gilbert's syndrome (unconjugated hyperbilirubinemia) have a total bilirubin \< 3 x ULN. * Aspartate aminotransferase (AST) * Alanine aminotransferase (ALT) \<2.5 x ULN * eGFR \>60 mL/min/1.73 Exclusion Criteria: 1. 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. 2. A medical history of significant liver disease or active liver disease. 3. A previous history of pure red blood cell remittance 4. 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 5. 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.) 6. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.). 7. 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 8. 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) 9. concurrent congestive heart failure (New York Heart Association \[NYHA\] class III or higher) 10. clinically significant ECG abnormalities at screening assessment. 11. Have been treated with any hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to randomization 12. have received treatment with an erythropoietic agent, androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 6 weeks prior to screening assessment. 13. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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