A Phase 2 interventional study of Active Comparator and ASCA101 24.32mg/kg in Cachexia; Cancer, sponsored by MetaFines. Recruiting at 6 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by MetaFines · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy and safety of ASCA101 for the treatment of Cachexia in solid tumor patients. The main questions it aims to answer are:
Can the efficacy of ASCA101 in improving cachexia be evaluated based on changes in body weight measured by InBody after 12 weeks (3 cycles) of weekly administration, compared to baseline, for each dose group?
Do participants experience adverse events during administration of ASCA101 and/or within 4 weeks after the end of administration?
This clinical trial comprises two parts. [Study 1. Active-Controlled, Open-Label Study] Participants who provide written informed consent will undergo screening procedures. Those who meet all inclusion criteria and none of the exclusion criteria will be eligible for enrollment and will be randomized to receive either ASCA101 (at one of two dose levels: 24.32 or 32.43 mg/kg) or an active control. Participants will receive the investigational product over 3 cycles (12 weeks). Each cycle consists of 28 days. Subjects in the ASCA101 group will receive the investigational drug twice weekly for a total of 8 doses per cycle. Participants in the active control group (megace F suspension) will receive the drug orally once daily.
[Study 2. Placebo-Controlled, Double-Blind Study] Participants who provide written informed consent will undergo screening procedures. Those who meet all inclusion criteria and none of the exclusion criteria will be eligible for enrollment and will be randomized to receive either ASCA101 (at one of two dose levels: 24.32 or 32.43 mg/kg) or placebo. Participants will receive the investigational product over 3 cycles (12 weeks). Each cycle consists of 28 days. Subjects in the ASCA101 group will receive the investigational drug twice weekly for a total of 8 doses per cycle. Participants in the placebo group will receive placebo in the same manner as the ASCA101 group.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 135 is above the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →MetaFines is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for enrollment, subjects must meet all of the following criteria.
Must be either surgically sterilized or *. (For female subjects only)
*Postmenopause is defined as the permanent cessation of ovarian function, evidenced by the absence of menstruation for 12 consecutive months not attributable to other medical causes.
Must meet at least one of the following criteria consistent with cachexia diagnosis*:
① Unintentional weight loss of >5% over the past 6 months.
② \<20 kg/m² with unintentional weight loss of >2% over the past 6 months.
③ Diagnosis of sarcopenia (skeletal muscle index: \<7.26 kg/m² for men, \<5.45 kg/m² for women) with unintentional weight loss of >2% over the past 6 months.
*For subjects requiring confirmation of sarcopenia for cachexia diagnosis, skeletal muscle mass must be assessed using Dual-Energy X-ray Absorptiometry (DEXA).
Clinical laboratory results measured within 14 days prior to randomization must meet the following criteria :
(ANC) ≥ 1,000/mm³
count ≥ 75,000/mm³
≥ 8.0 g/dL ④ Serum creatinine ≤ 2 × (ULN) ⑤ Total ≤ 3 × ULN ⑥ and ALT ≤ 3 × ULN (≤ 5 × ULN if liver is present)
Male subjects who have not undergone vasectomy must agree to use highly effective from at least 4 weeks prior to study drug administration, throughout the study period, and for 6 months following the last dose.
Highly effective contraception includes: partner's hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, or total sexual abstinence.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from enrollment.
Patients who meet any of the following criteria:
① Are scheduled to undergo surgery requiring general anesthesia for the treatment of cancer.
② Are scheduled to switch to, or initiate an additional anticancer treatment regimen other than the chemotherapy (including chemoimmunotherapy) or radiotherapy currently being administered.
③ Are receiving, or are scheduled to receive, hormonal therapy or immunotherapy.
Weight loss due to causes other than , including:
History of any of the following cardiovascular conditions within the past 5 years:
Congestive heart failure (CHF) classified as Class II or higher, or
Patients with one or more to ascorbic acid injection and/or calcium injection, including:
Patients with a history of bleeding-related or gastrointestinal diseases, as described below:
Patients requiring continuous systemic corticosteroid therapy (exceptions allowed as below):
Any other condition deemed by the investigator to make the patient unsuitable for participation in the clinical trial.
[Exclusion Criteria Applicable Only to Study 1]
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASCA101 injection 24.32 mg/kg administered twice a week in study 1
Drug: ASCA101 24.32mg/kg
ASCA101 injection 32.43 mg/kg administered twice a week in study 1
Drug: ASCA101 32.43mg/kg
Megace F suspension 625mg(5mL) administered daily in study 1
Drug: Active Comparator
ASCA101 injection 24.32 mg/kg administered twice a week in study 2
Drug: ASCA101 24.32mg/kg
ASCA101 injection 32.43 mg/kg administered twice a week in study 2
Drug: ASCA101 32.43mg/kg
0.9% normal saline injection
Drug: Placebo
Megace F suspension 625mg(5mL), intake daily for 12weeks
ASCA101 Inj. 24.32mg/kg, twice a week for 12 weeks
ASCA101 Inj. 32.43mg/kg, twice a week for 12 weeks
0.9% normal saline injection
Change in body weight at the end of cycle 3 compared to baseline
Change in body weight measured by InBody at the end of cycle 3 compared to baseline
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days.)
Change in body weight at the end of cycle 1 & cycle 2 compared to baseline
Change in body weight measured by InBody at the end of cycle 1 \& cycle 2 compared to baseline
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2. (Each cycle is 28days)
Percentage of subjects with ≥5% increase in body weight at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Percentage of subjects with ≥5% increase in body weight measured by InBody at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in body weight at the end of cycle 1, cycle 2 and cycle 3 compared to baseline measured by DEXA
Change in body weight(unit: kilograms) measured by DEXA(Dual-Energy X-ray Absorptiometry) at the end of cycle 1, cycle 2 and cycle 3 compared to baseline.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in appendicular skeletal muscle mass (ASM) at the end of cycle 1, cycle 2 and cycle 3 compared to baseline measured by DEXA
Change in ASM (unit: kilograms) measured by DEXA (Dual-Energy X-ray Absorptiometry) at the end of cycle 1, cycle 2 and cycle 3 compared to baseline. ASM is calculated by summing the lean soft tissue mass of the arms and legs (appendicular regions) measured by DEXA.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in appendicular bone mineral content at the end of cycle 1, cycle 2 and cycle 3 compared to baseline measured by DEXA
Change in appendicular bone mineral content(unit: grams or kilograms) measured by DEXA(Dual-Energy X-ray Absorptiometry) at the end of cycle 1, cycle 2 and cycle 3 compared to baseline. It is calculated by measuring the bone mineral content (BMC) of the arms and legs using DEXA and then summing the values.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in appendicular skeletal muscle mass index (ASMI) at the end of cycle 1, cycle 2 and cycle 3 compared to baseline measured by DEXA
Change in ASMI (unit: kg/m²) measured by DEXA(Dual-Energy X-ray Absorptiometry) at the end of cycle 1, cycle 2 and cycle 3 compared to baseline. It is calculated by dividing ASM (kg) by height squared (m²).
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in lean body mass and fat mass at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Change in lean body mass and fat mass (unit: kilograms) measured by InBody and DEXA the end of cycle 1, cycle 2 and cycle 3 compared to baseline.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in skeletal muscle mass and lower limb muscle mass at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Change in skeletal muscle mass and lower limb muscle mass measured by InBody at the end of cycle 1, cycle 2 and cycle 3 compared to baseline.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in Timed Up and Go test (TUG) results at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
The Timed Up and Go (TUG) test is performed with the patient starting in a seated position. Upon a signal, the patient stands up, walks approximately 3 meters (10 feet), turns around, and returns to sit in the chair. The time taken (in seconds) to complete this task is measured. Completion within 10 seconds is considered normal, and longer times are interpreted as indicating reduced mobility and increased risk of falls.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3 (each cycle is 28days)
Change in PGIC-C and PGIC-S at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Both PGIC-C and PGIC-S are patient-reported outcome (PRO) measures used to directly assess the patient's perceived change in condition following treatment. PGIC-C (Patient Global Impression of Change - Condition) evaluates the patient's overall change in condition using a 7-point Likert scale, with scores of 1-2 indicating marked improvement and scores of 5-7 indicating worsening. PGIC-S (Patient Global Impression of Change - Symptoms) assesses the patient's perceived change in specific symptoms, also using a 7-point Likert scale, with scores of 1-2 indicating marked improvement in symptoms and scores of 5-7 indicating worsening of symptoms.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in FAACT - Appetite domain score at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Change in FAACT(Functional Assessment of Anorexia/Cachexia Therapy) - Appetite domain score at the end of cycle 1, cycle 2 and cycle 3 compared to baseline. FAACT - Appetite domain score is a patient-reported outcome (PRO) measure used to assess the patient's appetite. Each item is rated on a 5-point Likert scale, and the domain score is calculated by summing the item scores. Higher scores indicate better appetite and lower symptom severity.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)
Change in FACIT-F score at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue) score is a patient-reported outcome (PRO) measure used to assess the level of fatigue in patients with chronic illnesses. It consists of 13 items, each rated on a 0-4 Likert scale. The total score is calculated by summing the item scores, with higher scores indicating less fatigue and better overall condition.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3 (each cycle is 28days)
Change in handgrip strength at the end of cycle 1, cycle 2 and cycle 3 compared to baseline
Handgrip strength is assessed using a digital or spring dynamometer, with the patient seated, elbow flexed at 90°, and wrist in a neutral position. Each hand is measured 1-3 times, and the maximum value is recorded. Grip strength criteria (kg) vary by sex and age group, and values below the reference are considered indicative of low muscle strength.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3 (each cycle is 28days)
Exploratory outcome : Adverse Events
Adverse events will be summarized by treatment group, including overall adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events leading to study discontinuation. For each category, the frequency, percentage, number of occurrences, and incidence rate will be presented along with two-sided 95% confidence intervals.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Clinical laboratory tests : Hematology Tests
To conduct Hematology Tests, blood samples are analyzed using an automated hematology analyzer. Parameters of the tests are White blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), platelets (PLT), etc.
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Clinical laboratory tests : Blood Chemistry Tests
To conduct Blood Chemistry Tests, using automated chemistry analyzer or immunoassay. Parameters of the tests are liver function (ALT, AST), kidney function (Creatinine, BUN), electrolytes (Na, K, Cl), glucose, lipids, etc.
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Clinical laboratory tests : Coagulation Tests
To conduct Coagulation Tests, plasma samples analyzed using an automated coagulation analyzer. PT (Prothrombin Time), aPTT (Activated Partial Thromboplastin Time), INR.
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Clinical laboratory tests : Urinalysis
To conduct Urinalysis, using reagent strips or an automated urine analyzer. Parameters of the test are color, specific gravity, pH, protein, glucose, red/white blood cells, ketones, etc.
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Vital signs : Blood pressure
Vital signs should be assessed prior to any planned procedures whenever possible, after the subject has rested in a seated position. Blood pressure measured in the seated position using an automated sphygmomanometer with an appropriately sized cuff. At least two readings will be obtained, separated by 1-2 minutes, and the average will be recorded. The unit of measurement for blood pressure is millimeters of mercury (mmHg).
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cyle is 28days.
Vital signs : Pulse
Pulse is measured simultaneously with blood pressure using the automated device, or manually by radial palpation for 30 seconds and extrapolated to beats per minute (bpm).
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cyle is 28days.
Vital signs : Body temperature
Body temperature is measured using a calibrated digital thermometer, preferably via the oral or tympanic route, and recorded in degrees Celsius (°C).
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cyle is 28days.
Exploratory outcome : Physical examination
At each visit, a physical examination will be performed, including inspection, palpation, percussion, and auscultation, to assess the subject's overall health and to identify any adverse events. The physical examination will include evaluation of the general appearance, skin, head/neck, chest/lungs, heart, abdomen, genitourinary system, extremities, musculoskeletal system, nervous system, and lymph nodes.
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Electrocardiogram (ECG) : PR interval, QRS interval, QT interval and QTc interval
PR interval, QRS interval, QT interval and QTc interval will be measured by ECG. All of them are expressed in milliseconds (ms). The PR interval, which measures the conduction time from the atria to the ventricles, has a normal range of 120-200 ms. The QRS complex, representing the duration and width of ventricular depolarization, has a normal range of 80-120 ms. The QT interval, representing the duration of ventricular depolarization and repolarization, can also be reported in its corrected form (QTc).
Time frame: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3, EOS (4 weeks after end of cycle 3). Each cycle is 28days.
Central lab assessments: GDF-15
Blood samples for central laboratory testing will be obtained after an overnight fast of at least 8 hours, prior to administration of the investigational medicinal product. Water intake is permitted during the fasting period. Samples will be collected in serum or plasma tubes, processed by centrifugation, stored at -80 °C, and shipped to the central laboratory for analysis. GDF-15 results are expressed in pg/mL. Elevated levels are associated with aging, cardiovascular disease, cancer, and cachexia.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. Each cycle is 28days.
Central lab assessments: Interleukin-1β (IL-1β)
Blood samples for central laboratory testing will be obtained after an overnight fast of at least 8 hours, prior to administration of the investigational medicinal product. Water intake is permitted during the fasting period. Samples will be collected in serum or plasma tubes, processed by centrifugation, stored at -80 °C, and shipped to the central laboratory for analysis. Interleukin-1β results are expressed in pg/mL. Detectable levels above baseline indicate systemic or local inflammatory activity.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. Each cycle is 28days.
Central lab assessments: Interleukin-6 (IL-6)
Blood samples for central laboratory testing will be obtained after an overnight fast of at least 8 hours, prior to administration of the investigational medicinal product. Water intake is permitted during the fasting period. Samples will be collected in serum or plasma tubes, processed by centrifugation, stored at -80 °C, and shipped to the central laboratory for analysis. Interleukin-6 measured using ELISA or electrochemiluminescence-based methods. Results are expressed in pg/mL. Increased concentrations reflect systemic inflammation, infection, or metabolic dysregulation.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. Each cycle is 28days.
Central lab assessments: Tumor Necrosis Factor-α (TNF-α)
Blood samples for central laboratory testing will be obtained after an overnight fast of at least 8 hours, prior to administration of the investigational medicinal product. Water intake is permitted during the fasting period. Samples will be collected in serum or plasma tubes, processed by centrifugation, stored at -80 °C, and shipped to the central laboratory for analysis. TNF-α quantified by ELISA or multiplex cytokine assay. Results are expressed in pg/mL. Elevated levels are associated with chronic inflammation, autoimmune disorders, and metabolic diseases.
Time frame: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. Each cycle is 28days.
Started May 2026 (actual). Primary completion is estimated for Apr 2028, 23 months after the start.
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