None listed
Conditions
Interventions
Drug : On Day 1 Cycle 1, ASCA101 will be given by intravenous (IV) infusion, followed by the second IV dose 2 to 3 days afterwards. Subsequently, ASCA101 IV will be given twice weekly at an interval o
if dose limiting toxicities (DLTs) are not observed, the study will proceed to the next dose level.
Sponsors
MetaFines
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients at the age of =19 years with histopathologically or cytologically confirmed metastatic or unresectable advanced solid tumors which progressed despite standard of care or which did not tolerate standard of care and for which other standard of care is not available. 2) Patients whose laboratory test values obtained within 14 days prior to study enrollment satisfy the followings (the patient must not have received G-CSF or blood transfusions within 14 days prior to the laboratory tests): ? ANC =1,500/mm³ ? Platelet count =100,000/mm³ ? Hemoglobin =9.0 g/dL ? Serum creatinine =1.5×ULN ? Total bilirubin =1.5×ULN ? AST, ALT =3×ULN (=5×ULN for patients with liver metastasis or liver cell carcinoma) ? INR and aPTT =1.5×ULN ? Urine protein to creatinine ration (UPC) <1.0 (g/g)a a UPC will be performed in patients with one positive (+) protein outcome upon urinalysis. 3) At least one evaluable lesion based on the response evaluation criteria in solid tumors (RECIST) version 1.1 as measured by tumor markers or CT/MRI. 4) Life expectancy =12 weeks. 5) Eastern Cooperative Oncology Group (ECOG) performance status =2. 6) Women of childbearing potential must be tested negative for pregnancy (to be performed by serum-hCG or urine-hCG at the discretion of the investigator) at the time of study participation. (All women who had menarche and were not surgically sterile (hysterectomy, bilateral tubal ligation, bilateral ovariectomy, etc.) and were not post-menopausal (no menstruation for =12 months for no particular reasons)) 7) Patients who agree to use medically acceptable methods of birth control (patient’s or partner’s vasectomy, tubal ligation, intrauterine device, barrier contraception, oral contraceptives, diaphragm or condom use in combination) during treatment with the investigational product (IP) and for 6 months after the end of treatment. 8) Patients who voluntarily provided written informed consent to study participation.
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivities to any of the components of the IP or the same class drugs. 2) At the time of screening: - 140/90 mmHg) - History of hypertension crisis or hypertensive encephalopathy - Pulmonary hypertension - Myocardial infarction - Significant vascular disease within 6 months prior to IP initiation (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) - Uncontrolled arrhythmia 4) Clinically significant NCI-CTCAE v5.0 Grade =2 toxicities persistent from previous anticancer treatment. 5) Severe infection or severe traumatic systemic disorders. 6) Symptomatic or uncontrolled metastasis to central nervous system (CNS) (a patient with asymptomatic CNS metastasis may participate in the study if systemic corticosteroids were discontinued =4 weeks prior and the patient is radiologically and neurologically stable for =4 weeks). 7) Severe neurological or psychiatric disorders that might have an impact on study results in the opinion of the investigator. 8) Pregnant or lactating women or patients planning a pregnancy during the study period. 9) Having participated in another clinical trial within 30 days prior to screening. 10) History of bleeding or digestive disorders: - Evidence of active bleeding, bleeding diathesis, coagulopathy, or tumor with macrovascular invasion - Clinically significant digestive ulcer, gastrointestinal (GI) bleeding, GI or non-GI fistula, perforation, intra-abdominal abscess, clinical symptoms and signs of GI obstruction, patient requiring parenteral fluids or nutrition, history of digestive disorders such as inflammatory bowel disease - Evidence of abdominal free air unexplained by recent surgery or paracentesis 11) Having been treated with biguanides (e.g., metformin) within 2 weeks prior to screening or anticipated to require biguanides during the study period. 12) Patient requiring continuous treatment with systemic corticosteroids (the followings will be permitted): - Corticosteroids: use of local corticosteroids such as local intra-articular, intra-nasal, intra-ocular, or inhaled corticosteroids or temporary use of systemic corticosteroids for the treatment and prevention of adverse events (AEs) or allergic reactions to contrast agents will be permitted. 13) Patient with HIV and other severe diseases based on which it is difficult to include the patient in the study (medically controlled diseases will be permitted). 14) Having ascites and/or pleural fluid drained within 14 days prior to screening. 15) Hemoptysis within 14 days prior to screening (=1/2 teaspoonful cherry red blood per episode). 16) Core biopsy or any other minor surgical procedure within 14 days pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Countries
Korea, Republic of
Contacts
Public Contactjiyoun an
MetaFines
Outcome results
None listed