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Cachexia; CancerPhase 2NCT07168226

Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101

A Phase 2 study testing Active Comparator, ASCA101 24.32mg/kg and ASCA101 32.43mg/kg in people with Cachexia; Cancer, run by MetaFines at 6 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Cachexia; Cancer
What is being tested?
Active Comparator, ASCA101 24.32mg/kg and ASCA101 32.43mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
6 sitesSouth Korea
Study dates
8 May 2026to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for enrollment, subjects must meet all of the following criteria.
  • Aged 19 years or older with a histologically or cytologically confirmed diagnosis of a solid tumor (primary tumor types: colorectal cancer, ovarian cancer, and lung cancer [lung cancer applicable to Study 1 only]).
  • Must be either surgically sterilized or postmenopausal*. (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.
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  • ② BMI <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 :
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 8.0 g/dL ④ Serum creatinine ≤ 2 × upper limit of normal (ULN) ⑤ Total bilirubin ≤ 3 × ULN ⑥ AST and ALT ≤ 3 × ULN (≤ 5 × ULN if liver metastasis is present)
  • INR and aPTT ≤ 1.5 × ULN
  • Able to consume food orally.
  • Able to complete questionnaires.
  • Life expectancy of at least 16 weeks, as assessed by the investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
  • Male subjects who have not undergone vasectomy must agree to use highly effective contraception 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.
  • Able and willing to voluntarily provide written informed consent to participate in this clinical trial.

Who cannot join

  • 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.
  • History of hypersensitivity to any component of the investigational product or to drugs of the same class.
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  • Currently taking medications for the purpose of appetite stimulation or weight gain.
  • History of surgery within 3 months prior to screening. (Note: Subjects undergoing postoperative chemotherapy are eligible regardless of the time of surgery.)
  • Subjects requiring dietary restrictions.
  • Subjects requiring enteral or parenteral nutrition.
  • Weight loss due to causes other than malignancy, including:
  • Major endocrine/metabolic disorders (e.g., hyperthyroidism, uncontrolled diabetes mellitus)
  • Conditions affecting appetite or calorie intake (e.g., mechanical bowel obstruction, cholestasis, uncontrolled nausea/vomiting, malabsorption syndromes, severe diarrhea)
  • Conditions that may lead to weight gain, including major endocrine/metabolic diseases (e.g., hypothyroidism, Cushing's syndrome).
  • History of any of the following cardiovascular conditions within the past 5 years:
  • Congestive heart failure (CHF) classified as NYHA Class II or higher, or LVEF
  • 50%
  • Uncontrolled hypertension
  • History of hypertensive crisis or hypertensive encephalopathy
  • Pulmonary hypertension
  • Myocardial infarction
  • Clinically significant vascular disease within 6 months prior to the first dose (e.g., aneurysm requiring surgery, recent peripheral arterial thrombosis)
  • Uncontrolled arrhythmias
  • Persistent clinically significant toxicity (Grade ≥2 per NCI-CTCAE v5.0) due to previous cancer treatment.
  • Subjects with severe infections or severe traumatic systemic conditions.
  • Symptomatic or uncontrolled central nervous system (CNS) metastases. (Note: Subjects with asymptomatic CNS metastases who have discontinued systemic corticosteroids at least 4 weeks prior to randomization and have been radiologically and neurologically stable for ≥4 weeks are eligible.)
  • Patients with one or more contraindications to ascorbic acid injection and/or calcium injection, including:
  • Hyperoxaluria, thalassemia
  • Gout, cystinuria
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Calcium oxalate nephrolithiasis
  • Receiving cardiac glycosides
  • Hypercalcemia (Ca ≥10.5 mg/dL)
  • History of kidney stones with hypercalciuria
  • Sarcoidosis
  • Nephrolithiasis
  • Hypoproteinemia (Total protein ≤6.0 g/dL)
  • Severe renal impairment (eGFR < 30 mL/min)
  • Patients with severe neurological or psychiatric disorders that, in the investigator's judgment, are sufficient to affect the clinical trial outcomes (e.g., depression, dementia, delirium).
  • Patients who are breastfeeding or who, or whose partners, are planning to become pregnant during the clinical trial period.
  • Individuals who have participated in another clinical trial within 30 days prior to screening.
  • Patients with a history of bleeding-related or gastrointestinal diseases, as described below:
  • Evidence of active bleeding, bleeding diathesis, coagulopathy, or tumors involving major blood vessels.
  • Clinically significant peptic ulcers, gastrointestinal bleeding, gastrointestinal or non-gastrointestinal fistulas, perforations, intra-abdominal abscesses, signs or symptoms of gastrointestinal obstruction, requirement of parenteral hydration or nutrition, or a history of inflammatory bowel disease (IBD).
  • Evidence of free air in the abdomen not explained by paracentesis or recent surgical procedures.
  • Patients who have received biguanides (e.g., metformin) within 2 weeks prior to screening or are expected to require them during the clinical trial.
  • Patients requiring continuous systemic corticosteroid therapy (exceptions allowed as below):
  • Use of local corticosteroids such as intra-articular, intranasal, ophthalmic, or inhaled corticosteroids is permitted.
  • Temporary systemic corticosteroid use for treatment or prevention of contrast agent allergy or adverse events is allowed.
  • Patients with HIV or other severe diseases deemed by the investigator to make study participation inappropriate.
  • Patients who underwent drainage of ascites and/or pleural effusion within 14 days prior to screening.
  • Patients with hemoptysis (defined as ≥1/2 teaspoon of bright red blood per episode) within 14 days prior to screening.
  • Patients who underwent core biopsy or other minor surgical procedures (excluding vascular access device placement) within 3 days prior to the first administration of the investigational product.
  • Patients with significant, unhealed wounds, active ulcers, or untreated fractures.
  • Patients with a history of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within 6 months prior to screening.
  • Patients with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • 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]
  • Patients with a history of hypersensitivity to megestrol acetate or any of its components.
  • Patients who have been receiving continuous antithrombotic therapy (antiplatelet agents, oral anticoagulants, or a combination thereof) within 4 weeks prior to screening, or who are anticipated to require antithrombotic therapy during the study period.
  • Patients with diabetes mellitus.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

JiYoun An contact

+82 70 7780 5569

jiyoun.an@metafines.com

6 sites in 1 country

South Korea6 sites, 6 recruiting

  • National Cancer Center

    Gyeonggi-do, Goyang-si

    Hanim Park, +82 10 3550 3718, park.hanim@lskglobal.com

    MyungCheol Lim, MD, PhD

    Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gyeonggi-do, Gwangmyeong-si

    Hanim Park, +82 10 3550 3718, park.hanim@lskglobal.com

    JungHye Kwon, MD, PhD

    Recruiting

  • Ajou University Hospital

    Gyeonggi-do, Suwon-si

    Hanim Park, +82 10 3550 3718, park.hanim@lskglobal.com

    SeokYun Kang, MD, MS

    Recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu

    Hanim Park, +82 10 3550 3718, park.hanim@lskglobal.com

    YouYoung Lee, MD, PhD

    Recruiting

  • Seoul ST. Mary's hospital

    Seoul, Seocho-gu

    Hanim Park, +82 10 3550 3718, park.hanim@lskglobal.com

    MyungAh Lee, MD, PhD

    Recruiting

  • Korea University Anam Hospital

    Seoul, Seongbuk-gu

    Hanim Park, +82 10 3550 3718, park.hanim@lskglobal.com

    YunJi Choi, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Phase 2 Clinical Trial to Exploratively Evaluate the Efficacy and Safety of ASCA101 for the Treatment of Cachexia in Patients With Solid Tumor

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?

Read more

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.

Being tested
Active Comparator, ASCA101 24.32mg/kg, ASCA101 32.43mg/kg, Placebo
Medical subject headings
Cachexia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active ComparatorDrug

    Megace F suspension 625mg(5mL), intake daily for 12weeks

  • ASCA101 24.32mg/kgDrug

    ASCA101 Inj. 24.32mg/kg, twice a week for 12 weeks

  • ASCA101 32.43mg/kgDrug

    ASCA101 Inj. 32.43mg/kg, twice a week for 12 weeks

  • PlaceboDrug

    0.9% normal saline injection

Study groups in NCT07168226
Study groupRoleWhat they receive
ASCA101 Inj. 24.32mg/kg #1ExperimentalASCA101 injection 24.32 mg/kg administered twice a week in study 1
Receives: Drug: ASCA101 24.32mg/kg
ASCA101 Inj. 32.43mg/kg #1ExperimentalASCA101 injection 32.43 mg/kg administered twice a week in study 1
Receives: Drug: ASCA101 32.43mg/kg
Megace F suspensionActive comparatorMegace F suspension 625mg(5mL) administered daily in study 1
Receives: Drug: Active Comparator
ASCA101 Inj. 24.32mg/kg #2ExperimentalASCA101 injection 24.32 mg/kg administered twice a week in study 2
Receives: Drug: ASCA101 24.32mg/kg
ASCA101 Inj. 32.43mg/kg #2ExperimentalASCA101 injection 32.43 mg/kg administered twice a week in study 2
Receives: Drug: ASCA101 32.43mg/kg
PlaceboPlacebo comparator0.9% normal saline injection
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days.)

Secondary outcomes (13)

  1. 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

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2. (Each cycle is 28days)

  2. 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

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  3. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  4. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  5. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  6. 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).

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  7. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  8. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  9. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3 (each cycle is 28days)

  10. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  11. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)

  12. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3 (each cycle is 28days)

  13. 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.

    Measured: At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3 (each cycle is 28days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start8 May 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168226
Sponsor's protocol ID
MF-ASCA101-03
Status last verified
Jun 2026
First submitted
26 Aug 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Active Comparator, ASCA101 24.32mg/kg and ASCA101 32.43mg/kg in people with Cachexia; Cancer, run by MetaFines at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 61 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JiYoun An (+82 70 7780 5569, jiyoun.an@metafines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight 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.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07168226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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