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Tests treatment safety and results for Cachexia; Cancer
Official title Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101
ClinicalTrials.gov ID: NCT07168226
What this study is testing
What is Active Comparator?
Active Comparator is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for cachexia; cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- To be eligible for enrollment, people 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...
- Must be either surgically sterilized or postmenopausal\ . (For female people only) \ Postmenopause is defined as the permanent cessation of ovarian...
- 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...
- Clinical laboratory results measured within 14 days prior to randomization must meet the following criteria :
You likely can't join if
- people 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...
- 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: people undergoing postoperative chemotherapy are eligible regardless of the time of...
- people requiring dietary restrictions.
See the full eligibility criteria
Who can join
- To be eligible for enrollment, people 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 people only) \ Postmenopause is defined as the permanent cessation of ovarian function, evidenced by the absence of menstruation for 12 consecutive...
- 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 BMI \ 2% over the past 6 months. ③ Diagnosis of sarcopenia (skeletal...
- 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 people 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...
- Able and willing to voluntarily provide written informed consent to participate in this clinical trial.
What rules you out
- people 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...
- 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: people undergoing postoperative chemotherapy are eligible regardless of the time of surgery.)
- people requiring dietary restrictions.
- people 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
- 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.
- people with severe infections or severe traumatic systemic conditions.
- Symptomatic or uncontrolled central nervous system (CNS) metastases. (Note: people with asymptomatic CNS metastases who have discontinued systemic corticosteroids at least 4 weeks prior to randomization and have been...
- 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...
- 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...
- Patients with diabetes mellitus.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Gangnam-gu, South Korea
- Gyeonggi-do, Goyang-si, South Korea
- Gyeonggi-do, Gwangmyeong-si, South Korea
- Seoul, Seocho-gu, South Korea
- Seoul, Seongbuk-gu, South Korea
- Gyeonggi-do, Suwon-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Gangnam-gu, South Korea; Gyeonggi-do, Goyang-si, South Korea; Gyeonggi-do, Gwangmyeong-si, South Korea; Seoul, Seocho-gu, South Korea; Seoul, Seongbuk-gu, South Korea; Gyeonggi-do, Suwon-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.