Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101
ConditionCachexia; Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorMetaFines
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Absolute Neutrophil Count (ANC) ≥ 1,000/mm³
Platelet count ≥ 75,000/mm³
Disqualifiers
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 3 months prior to screening. (Note: Subjects undergoing postoperative chemotherapy are eligible regardless of the time of surgery.)
Subjects requiring dietary restrictions.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Comparator
DrugMegace F suspension 625mg(5mL), intake daily for 12weeks
ASCA101 24.32mg/kg
DrugASCA101 Inj. 24.32mg/kg, twice a week for 12 weeks
ASCA101 32.43mg/kg
DrugASCA101 Inj. 32.43mg/kg, twice a week for 12 weeks
Placebo
Drug0.9% normal saline injection
Treatment groups
135 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: ASCA101 Inj. 24.32mg/kg #1Experimental treatment 1 intervention
Group B: ASCA101 Inj. 32.43mg/kg #1Experimental treatment 1 intervention
Group C: Megace F suspensionActive comparator 1 intervention
Group D: ASCA101 Inj. 24.32mg/kg #2Experimental treatment 1 intervention
Group E: ASCA101 Inj. 32.43mg/kg #2Experimental treatment 1 intervention
Group F: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
At Screening, baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days.)Secondary outcomes
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
Time frame
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
Time frame
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.
Time frame
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.
Time frame
At baseline(0 week), End of Cycle 1, End of Cycle 2, End of Cycle 3. (Each cycle is 28days)Other outcomes
1
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.2
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.3
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.4
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. Source ClinicalTrials.gov