Advanced malignant solid tumor
Conditions
Interventions
Phase I, Dose Group 1:Group A: 4mg/dose, single dose, total dose 4mg
Group B: 4mg/dose, 2x/day, day 1 only, total dose 8mg
Mode of administration: Oral
Phase ? Dose Group 2:Oral drug 8mg, single + 2 consecutive multiple administrations/day
Phase ? Dose Group 3:Oral drug 16mg, single dose + 2 consecutive multiple doses/day
Phase ? Dose Group 4:Oral drug 24mg, single dose + 2 consecutive multiple doses/day
Phase I, Dose Group 5:Oral drug 32mg, single dose + 2 consecutive multiple doses/day
? phase 6 dose group:Oral drug 40mg, single dose + 2 consecutive multiple doses/day
Phase II (Cohort A colorectal cancer):Mode of administration: Oral
Dosage: 2. 20mg qd (body weight >=55kg)
2. 16mg qd (body weight =55kg)
2.16mg qd (body weight =55kg)
2. 16mg qd (body weight <55kg)
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign an informed consent form and comply with the requirements of the plan; 2. 18 years old = 12 weeks; 4. Physical condition score ECOG = 1.5 × 10^9/L, platelet count >= 75 × 10^9/L, hemoglobin >= 90g/L, and no platelet or red blood cell transfusion within 14 days before the first administration, and no blood transfusion or biological response regulator treatment (such as granulocyte growth factor, erythropoietin, interleukin-11, etc.) has been received within 14 days before the first administration; (2) Liver function: No history of cirrhosis (decompensated cirrhosis Child Pugh B, C grade). Patients without liver metastasis require serum total bilirubin (TBIL) 50mL/min (Cockcorft Gault formula); Qualitative analysis of urine protein = 2+, a 24-hour quantitative urine protein test is required; Researchers make inclusion judgments based on the examination results; (4) Coagulation function: prothrombin time (PT) <= 1.5 times ULN; International normalized ratio (INR) <= 1.5 × ULN, with activated partial thromboplastin time (APTT) <= 1.5 × ULN; 9. Female participants of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive measure (such as an intrauterine device, pregnancy avoidance medication, or condom) during the study period and within 3 months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration.
Exclusion criteria
Exclusion criteria: 1. Previously or currently suffering from other types of malignant tumors, but the following situations should be excluded: (1). Radical skin basal cell carcinoma, superficial bladder cancer cancer, skin squamous cell carcinoma or cervical carcinoma in situ; (2). Second primary cancer that has been cured and has not recurred within five years; 2. For patients who are allergic to any component of the investigational drug or have a history of severe allergies; 3. Received any of the following treatments or medications before the first study treatment: (1). For the first study, major surgery or severe trauma occurred within 4 weeks prior to drug treatment (defined as any invasive surgery that involves extensive resection or surgery that requires opening of the mesothelial cell barrier (such as pleural cavity, peritoneum, meninges). However, tissue biopsy required for diagnosis is allowed. Severe trauma refers to the presence of unhealed wounds, ulcers, or fractures; (2). For the first study, there were indications for anti-tumor treatment with Chinese (patent) drugs within 2 weeks prior to drug treatment. (3). Received anti-tumor treatment (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biological therapy, or tumor embolization) within 4 weeks prior to the first administration; For oral fluorouracil drugs and endocrine therapy, discontinuation of medication for = NYHA level II; Left ventricular ejection fraction (LVEF)450 milliseconds, female>470 milliseconds, or presence of risk factors for torsade de pointe ventricular tachycardia, such as clinically significant hypokalemia, family history of long QT syndrome, or family history of arrhythmias (such as preexcitation syndrome) as determined by the researcher; (4). Have experienced myocardial infarction and severe/unstable angina within six months prior to administration; (5). Have a history of >= grade 3 thromboembolic events within the past 2 years, or are currently receiving thrombolytic or anticoagulant treatment due
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose restriction toxicity (DLT) Maximum tolerated dose (MTD);Adverse Events (AE), Serious Adverse Events (SAE), Laboratory Tests, Vital Signs, Physical Examination, Imaging, 12-Lead ECG;Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of single / multiple administration of ABP1011T tablet;Objective response rate (ORR);Disease control rate (DCR);Adverse Events (AE), Serious Adverse Events (SAE), Laboratory Tests, Vital Signs, Physical Examination, 12-Lead ECG, ECOG Score;duration of response (DOR);Progression-free survival (PFS);overall survival (OS);disease control rate (DCR);duration of response (DOR);Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactBinghe Xu
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed