New pill aims to boost red blood cells in cancer patients

NCT ID NCT06075043

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2027

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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