An Open-Label, Multi-Cohort Phase IIb Clinical Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors
This study is a multicenter, open-label, multi-cohort investigation exploring the efficacy and safety of ABP1011T tablets in participants with specific target solid tumors, providing a foundation for subsequent clinical research. Based on safety and efficacy data from the prior Phase I/IIa clinical trial (Protocol Number: ABP1011T-I/II-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma). ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).
• Voluntarily sign the informed consent form and comply with protocol requirements;
• Age 18 \<= age \<= 75 years, male or female;
• Expected survival \>= 12 weeks;
• ECOG performance status \<= 1 point;
• Patients with advanced solid tumors who have experienced disease progression on standard therapy, intolerance to standard therapy, or lack of effective standard therapy, with histopathological or cytopathological confirmation (priority enrollment for small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, renal cell carcinoma, or other potentially sensitive tumor types. Cohort A is the small cell lung cancer cohort: includes patients who have failed at least two prior systemic therapies; Cohort B includes patients with other advanced solid tumors); At least one measurable lesion meeting RECIST v1.1 criteria;
• Recovery from toxic effects of the last prior treatment (CTCAE \<= Grade 1, except for specific conditions such as alopecia or hyperpigmentation), and the investigator determines that the corresponding AE poses no safety risk;
• Systolic blood pressure \<= 140 mmHg, diastolic blood pressure \<= 90 mmHg, with no changes in antihypertensive medications or dosages within 7 days prior to the first dose.
• Organ and bone marrow function levels must meet the following requirements: Bone marrow: Absolute neutrophil count (ANC) \>= 1.5 × 10\^9/L, platelet count \>= 75 × 10\^9/L, Hemoglobin \>=90 g/L, with no transfusion of platelets or red blood cells within 14 days prior to the first dose, and no transfusion or treatment with biological response modifiers (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11) within 14 days prior to the first dose; Liver function: No history of liver cirrhosis (decompensated cirrhosis Child-Pugh B or C). For patients without liver metastases: serum total bilirubin (TBIL) \<= 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 × ULN. Patients with liver metastases must have TBIL \<= 2.5×ULN, ALT and AST \<= 5×ULN. Renal function: Serum creatinine \<= 1.5×ULN, or creatinine clearance \> 60 mL/min (Cockcroft-Gault formula); Urine protein qualitative \<= 1+; If urine protein qualitative \>= 2+, 24-hour urine protein quantification is required. The investigator will determine eligibility based on test results. Coagulation function: Prothrombin time (PT) \<= 1.5 × ULN; International Normalized Ratio (INR) \<= 1.5 × ULN, and activated partial thromboplastin time (APTT) \<= 1.5 × ULN.
• Female subjects of childbearing potential must undergo a serum pregnancy test within 3 days prior to initiating study medication, with negative results, and must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study period and for 6 months after the last study dose. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months after the last study dose.