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

NCT07168226 | Not Yet Recruiting Phase 2

• 1 other identifier: MF-ASCA101-03
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 6

Brief 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) 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.

Conditions

Cachexia; Cancer

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (13)

• Change in body weight at the end of cycle 1 & cycle 2 compared to baseline

  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

  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

  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

  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

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

Other Outcomes (14)

• Exploratory outcome : Adverse Events

  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

  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

  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.

Study Arms (6)

ASCA101 Inj. 24.32mg/kg #1

EXPERIMENTAL

ASCA101 injection 24.32 mg/kg administered twice a week in study 1

Drug: ASCA101 24.32mg/kg

ASCA101 Inj. 32.43mg/kg #1

EXPERIMENTAL

ASCA101 injection 32.43 mg/kg administered twice a week in study 1

Drug: ASCA101 32.43mg/kg

Megace F suspension

ACTIVE COMPARATOR

Megace F suspension(20mL) administered daily in study 1

Drug: Active Comparator

ASCA101 Inj. 24.32mg/kg #2

EXPERIMENTAL

ASCA101 injection 24.32 mg/kg administered twice a week in study 2

Drug: ASCA101 24.32mg/kg

ASCA101 Inj. 32.43mg/kg #2

EXPERIMENTAL

ASCA101 injection 32.43 mg/kg administered twice a week in study 2

Drug: ASCA101 32.43mg/kg

Placebo

PLACEBO COMPARATOR

0.9% normal saline injection

Drug: Placebo

Interventions

Active Comparator DRUG

Megace F suspension 20mL, intake daily for 12weeks

Megace F suspension

ASCA101 24.32mg/kg DRUG

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

ASCA101 Inj. 24.32mg/kg #1; ASCA101 Inj. 24.32mg/kg #2

ASCA101 32.43mg/kg DRUG

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

ASCA101 Inj. 32.43mg/kg #1; ASCA101 Inj. 32.43mg/kg #2

Placebo DRUG

0.9% normal saline injection

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[lung cancer applicable to Study 1 only\]).
• (For female subjects only): Must be either surgically sterilized or postmenopausal\*.
• \*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, or
• ② BMI \<20 kg/m² with unintentional weight loss of \>2% over the past 6 months, or
• 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 (without G-CSF administration or blood transfusion within 14 days prior to lab tests):
• Absolute Neutrophil Count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³ ③ Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN) ⑤ Total bilirubin ≤ 1.5 × ULN ⑥ AST and ALT ≤ 3 × ULN (≤ 5 × ULN if liver metastasis is present) ⑦ 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.

You may not qualify if:

• Subjects scheduled to undergo surgery for cancer treatment or currently receiving/planned to receive non-chemotherapy anticancer therapies such as radiotherapy, hormone therapy, or immunotherapy.
• History of hypersensitivity to any component of the investigational product or to drugs of the same class.
• Currently taking medications for the purpose of appetite stimulation or weight gain.
• History of surgery within 6 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
• Uncontrolled hypertension (SBP/DBP \>140/90 mmHg)
• History of hypertensive crisis or hypertensive encephalopathy
• Pulmonary hypertension

Sponsors & Collaborators

• MetaFines: lead

Study Sites (6)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Location

National Cancer Center

Gyeonggi-do, Goyang-si, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeong-si, South Korea

Location

Seoul ST. Mary's hospital

Seoul, Seocho-gu, South Korea

Location

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

Location

Ajou University Hospital

Gyeonggi-do, Suwon-si, South Korea

Location

MeSH Terms

Conditions

Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Central Study Contacts

JiYoun An

CONTACT

+82 70 7780 5569; jiyoun.an@metafines.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: September 30, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

KR (6)