HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies

NCT07891377 | Not Yet Recruiting Phase 2

• 1 other identifier: HEC53856-CIA-202
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II clinical trial to evaluate the efficacy and safety of different dosing regimens of HEC53856 tablets compared to rHuEPO injection in participants of the CIA trial.

Conditions

Chemotherapy-induced Anemia; Non-Myeloid Malignancy

Outcome Measures

Primary Outcomes (1)

• The compliance rate of hemoglobin (Hb) in trial participants at week 7

  The proportion of participants who met the hemoglobin (Hb) standard (defined as 100\<Hb ≤ 120 g/L) in the 7th week

  Week 7

Secondary Outcomes (9)

• Hemoglobin (Hb) Response Rate

  Up to around 15 weeks

• The average Hb compliance rate of participants at each preset visit point during the trial period

  Up to around 15 weeks

• Mean change of Hb

  From Week 7 to around week 15

• The proportion of trial participants with Hb increased by ≥10 / 15 / 20 g/L from baseline

  Up to around 15 weeks

• The time when Hb increased by ≥10 /15/20 g/L compared to baseline

  Up to around 15 weeks

Study Arms (2)

HEC53856 Tablets

EXPERIMENTAL

Participants in the experimental cohort will take HEC53856 tablets orally, each treatment cycle is 3 weeks. The treatment will continue until the termination criteria are met, and the dosage can be adjusted according to the protocol standards.

Drug: HEC53856 tablet

rHuEPO injection

ACTIVE COMPARATOR

Participants in the positive control group are administered rHuEPO injection. Each treatment cycle is 3 weeks and treatment will continues until the termination criteria are met. The dosage can be adjusted according to the instructions or plan.

Drug: rHuEPO injection

Interventions

HEC53856 tablet DRUG

The experimental cohort is divided into four groups: 20 mg once a day (QD) group, 40 mg QD group, 60 mg QD group, and 100 mg three times a week \[TIW\] group. Participants in the experimental cohort will take HEC53856 tablets orally either in the fasted state or after meals.

HEC53856 Tablets

rHuEPO injection DRUG

rHuEPO Injection 36000 IU will be subcutaneously administered once weekly \[QW\].

rHuEPO injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, weight ≥ 40 kg, gender not limited;
• Diagnosed as non myeloid malignant tumor through histology or cytology;
• Bone marrow suppression chemotherapy related anemia, defined as Hb ≤ 100 g/L during the screening period, and according to the researcher's judgment, there are records showing that the Hb level of the trial participants has decreased by ≥ 10 g/L after the start of previous chemotherapy;
• Plan to receive at least 6 weeks of tumor treatment simultaneously ;
• Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;
• Expected survival time ≥ 6 months;
• ferritin ≥ 50 ng/mL and transferrin saturation (TSAT) ≥ 10%;
• Participants in the experiment must have appropriate organ function and meet all of the following laboratory test results before enrollment:
• Liver function: ALT and AST ≤ 3 × ULN; Serum bilirubin ≤ 1.5 × ULN;
• Renal function: According to the 4-variable MDRD equation, the estimated glomerular filtration rate (eGFR) is ≥ 50 mL/min/1.73 m2.
• Non lactating female trial participants; For female trial participants with fertility: During the screening period, the blood pregnancy test must benegative, and from informed consent signature through 3 months following the last study treatment dose have no plan for oocyte retrieval for in-vitro fertilization (IVF) and must agree to take effective contraceptive measures.
• For male trial participants who have not been sterilized: from informed consent signature through 3 months following the last study treatment dose,have no plan to donate sperm and must agree to take effective contraceptive measures.
• The definition and contraception guidelines for "women with fertility" can be found in section 15.3.
• Voluntarily participate in this study and sign a written informed consent form.

You may not qualify if:

• Participants receiving bone marrow suppressive chemotherapy with an expected outcome of cure;
• Uncontrolled central nervous system metastasis; Or confirm central nervous system metastasis, but have not been stabilized for more than 4 weeks after anti-tumor treatment (definition of stable central nervous system metastasis: no new neurological deficits caused by central nervous system metastasis have been found, no new lesions have been detected by central nervous system imaging examination, and no corticosteroid/steroid treatment is needed); Or malignant neoplasms with primary central nervous system origin or bone-marrow involvement, or malignant tumors of the myeloid system (such as chronic myeloid leukemia, etc.);
• Hematocrit (HCT) ≥ 36%;
• Plan to undergo major surgery during the treatment period;
• traditional Chinese patent medicines and simple preparations that has received anemia treatment within 2 weeks before randomization or RBC infusion or anemia treatment drugs within 4 weeks before randomization, including but not limited to erythropoiesis stimulators (ESAs) and their derivatives, hypoxia inducible factor proline hydroxylase (HIF-PHD) inhibitor, androgen and anabolic hormone drugs;
• Receive live vaccines (including attenuated live vaccines) within the first 4 weeks of randomization;
• Participants who have participated in any interventional clinical trials and received investigational drugs or medical device interventions within the first 4 weeks of randomization (excluding participants in overall survival follow-up trials who only participated in one study), or plan to use these drugs during their participation in this clinical trial;
• Only accept hormone preparations, biologics, novel immunosuppressive agents (such as PD-1 and PD-L1 immune checkpoint inhibitors), targeted biotherapy, or radiation therapy to treat/control their tumors. Note: If chemotherapy is combined with these drugs or if the treatment received contains antibody conjugated drugs (ADCs), it can be included in the study;
• Currently using or expected to use dapsone during the study treatment period;
• There is known, active, or chronic bleeding present;
• Anemia of clinical significance caused by other etiologies, such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, sickle cell anemia or thalassemia, etc;
• Persistent inflammation/autoimmune diseases that are clinically significant or uncontrolled (such as rheumatoid arthritis, Crohn's disease, celiac disease, etc.);
• Any of the following cardiovascular risk factors:
• Any history of significant clinical arrhythmia (such as rapid atrial fibrillation, high-grade atrioventricular block, ventricular tachycardia, ventricular fibrillation, or apical torsion ventricular tachycardia);
• Left ventricular ejection fraction (LVEF) is less than 50% during the screening period;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Central Study Contacts

Lu Shun, MD

CONTACT

86+021-22200000-3403; shun_lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)