Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101 (NCT07168226) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101
South Korea135 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion 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 \[lung cancer applicable to Study 1 only\]).
✓. (For female subjects only): Must be either surgically sterilized or postmenopausal\*.
✓. Must meet at least one of the following criteria consistent with cachexia diagnosis\*:
✓. 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):
✓. 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 of 0, 1, or 2.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in body weight at the end of cycle 3 compared to baseline
Timeframe: At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days.)
✕. 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:
✕. Conditions that may lead to weight gain, including major endocrine/metabolic diseases (e.g., hypothyroidism, Cushing's syndrome).