Advanced solid tumor
Conditions
Interventions
Trial group:ABP1618 Tablet
Sponsors
Zhongshan Hospital, Fudan University
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 = age = 65 years old, no gender limit; (3) Expected survival time = 12 weeks; (4) ECOG = 1 point (for patients with solid tumors other than gliomas), or KPS = 60 point (for patients with gliomas); (5) Phase I studie: patients with advanced solid tumors with disease progression despite standard therapy, intolerance of standard therapy, or lack of effective standard therapy, and a pathologically or cytologically confirmed diagnosis; at least 1 measurable lesion that meets the criteria of the Response to Criteria for Evaluation of Efficacy in Solid Tumors (RECIST) v1.1; Phase II studie: patients with esophageal, glioblastic and cervical cancers or other sensitive tumors that have failed or are intolerant to standard therapy and have a pathologically or cytologically confirmed diagnosis; and at least 1 measurable lesion that meets the criteria of RECIST v1.1 (for glioblastomas, there is at least one intracranial measurable tumor lesion by RANO criteria); (6) Patients who have recovered from the toxic effects of the last previous treatment prior to the first dose (CT CAE = Grade 1, except for "alopecia", "hyperpigmentation", etc.) and who, in the judgment of the investigator, do not pose a safety risk with respect to the corresponding AE; (7) Systolic blood pressure =140 mmHg and diastolic blood pressure =90 mmHg with no change in antihypertensive medication or dosage within 7 days prior to the first dose. (8) Organ and bone marrow function levels must meet the following requirements: Bone marrow: absolute neutrophil count (ANC) = 1.5 x 109/L, platelet count = 100 x 109/L, hemoglobin = 90 g/L, and no platelet or red blood cell transfusion within 14 days prior to the first administration of the drug, and no transfusion or treatment with biological response modifiers (e.g., granulocyte growth factor, erythropoietic growth factor, interleukin-11, etc.) within 14 days prior to the first administration of the drug Hepatic function: no history of cirrhosis; Liver function: no history of cirrhosis (decompensated cirrhosis Child-Pugh class B or C). Patients without liver metastases should have serum total bilirubin (TBIL) =1.5 x upper limit of normal (ULN) (except for unconjugated hyperbilirubinemia or Gilbert's syndrome) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 x ULN. Patients with liver metastases should have TBIL =2.5 x ULN and ALT and AST =5 x ULN; Renal function: serum creatinine = 1.5 × ULN, or creatinine clearance > 50 mL/min (Cockcorft-Gault formula); urine protein characterization = 1+; if urine protein characterization = 2+, 24-h urine protein quantification and < 1 g of protein in the urine over a 24-hour period; enrollment is based on the results; Coagulation: prothrombin time (PT) = 1.5 times ULN; International Normalized Ratio (INR) = 1.5 x ULN and activated partial thromboplastin time (APTT) = 1.5 x ULN. (9) Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study drug administration and be willing to use a medically approved highly effective contraceptive method (e.g., IUD, birth control pills, or condoms) for the duration of the study and for a period of 6 months following the final administration of study drug; (9) For male participants whose partners are women of childbearing age
Exclusion criteria
Exclusion criteria: (1) Previous or current malignant tumors of other types, except for the following: a) Radically treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ; b) Second primary cancers that have been eradicated and have not recurred within five years; (2) Patients who are allergic to any component of the study drug or have a previous history of severe allergy; (3) Received any of the following treatments or medications prior to the first study treatment: a) Major surgery or severe trauma within 4 weeks prior to the first study drug treatment (major surgery is defined as any invasive procedure in which extensive resection is performed or in which the mesothelial cell barrier (e.g., pleural cavity, peritoneum, meninges) is required to be opened. However, tissue biopsies required for diagnostic purposes are permitted. Severe trauma is defined as the presence of unhealed wounds, ulcers, or fractures; b) Chinese (adult) medicine therapy with an antitumor indication within 2 weeks prior to the first study drug treatment. c) Anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first dose of study medication; = 2 weeks of discontinuation in the case of oral fluorouracil analogs and endocrine therapy; = 6 weeks of discontinuation in the case of nitrosoureas, mitomycin, or monoclonal antibodies. If the elution time is not adequate due to scheduling or drug PK properties, this needs to be discussed with the sponsor ;-) d) Received a drug known to significantly prolong the QT interval (e.g., class Ia and class III antiarrhythmics) within 1 week prior to the first dose; (4) Patients with a history of CNS metastases (non-tumor meningeal metastases in patients) or spinal cord compression may be enrolled in the study if definitively treated, clinically stable, asymptomatic, and clinically stable after discontinuing anticonvulsants and steroids for 4 weeks prior to the first dose of the study; (5) Patients with symptomatic, advanced disease that has disseminated to the viscera and is at risk of life-threatening complications in the short term, and patients with pleural effusions, peritoneal effusions, and pericardial effusions who have had a puncture and drainage within three weeks prior to the first dose of study drug; (6) Imaging evidence of major vascular infiltration (e.g., pulmonary artery, superior vena cava, or inferior vena cava), significant tumor invasion into the esophagus or organs adjacent to the gastrointestinal tract lesion (large arteries or trachea or gastrointestinal tract) resulting in a high risk for hemorrhage or fistulae; and patients with post-tracheal endoluminal stenting. (7) Cardiovascular disease meeting any of the following criteria in the 6 months prior to screening: a) Congestive heart failure with cardiac function = New York Heart Association (NYHA) class II; left ventricular ejection fraction (LVEF) 450 ms in men and >470 ms in women, or the presence of risk factors for tip-twisting ventricular tachycardia, such as hypokalemia judged by the investigator to be clinically significant, a history of familial long QT syndrome, or a history of familial arrhythmias (e.g., pre-excitation syndrome); d) Unstable angina, myocard
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in data indicators detected by adverse event records, physical examination, vital signs, physical status ECOG score/Karnofsky score, laboratory tests, ECG, echocardiography.;Maximum tolerated dose (MTD);Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of single / multiple administration of ABP1618 tablet;Change in QTcF (?QTcF) relative to baseline at selected times after single and multiple oral doses of ABP1618 tablets.;Objective remission rate, disease control rate, duration of remission, progression-free survival, overall survival, 6-month progression-free survival rate, 6-month DOR rate, 12-month progression-free survival rate, 12-month overall survival rate, 24-month progression-free survival rate, 24-month overall survival rate.;Changes in data indicators detected by adverse event records, physical examination, vital signs, physical status ECOG score/Karnofsky score, laboratory tests, ECG, echocardiography.; | — |
Countries
China
Contacts
Public ContactTianshu Liu
Zhongshan Hospital, Fudan University
Outcome results
None listed