A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer-Related Anemia
• Intervention / Treatment: Drug: AND017

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yusha Zhu, MD, PhD; Phone Number: 6467252552; Email: yushazhu@kindpharmaceutical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AND017 Dose A three times weekly	Drug: AND017; Oral administration of AND017 capsules three times per week
Experimental: AND017 Dose B three times weekly	Drug: AND017; Oral administration of AND017 capsules three times per week
Experimental: AND017 Dose C three times weekly	Drug: AND017; Oral administration of AND017 capsules three times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to Week 6 or End of Treatment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion treatment rate	The percentage of subjects who need to receive blood transfusion during the trial	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	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	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	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	From Baseline to Week 6 or at End of Treatment visit

Collaborators and Investigators

• Sponsor: Kind Pharmaceuticals LLC
• Investigators: Study Director: Yusha Zhu, MD, PhD, Kind Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: AND017-CRA-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No