About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
Hepatitis B (HBV) (requiring both positive hepatitis B surface antigen (HBsAg) and HBV-DNA levels exceeding the center's specified detection limit);
Hepatitis C (requiring both HCV antibody [HCV-Ab] positivity and HCV-RNA levels exceeding the lower limit of detection for the analytical method);
Active local or systemic infection requiring systemic antimicrobial therapy within 4 weeks prior to first dosing, or unexplained fever >38.5°C during screening/prior to first dosing;
Active pulmonary tuberculosis infection identified through medical history or CT examination, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment; 14. Individuals with positive human immunodeficiency virus (HIV RNA) or Treponema pallidum antibody status; 15. Presence of multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or conditions judged by the investigator to severely impair gastrointestinal absorption; 16. History of confirmed neurological or psychiatric disorders, including epilepsy, dementia, depression, etc.; 17. Patients with alcohol or drug dependence, a history of needle phobia or blood phobia, or inability to tolerate venous blood collection; 18. Habitual consumption of grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, with inability to discontinue during the trial period; 19. Received any investigational drug within 4 weeks prior to first dosing, or concurrent participation in another clinical study (except: participation in an observational, non-interventional clinical study; being in the follow-up period of an interventional clinical study; or completion of the previous study drug administration more than 5 half-lives ago); 20. Female patients who are pregnant or breastfeeding; 21. Patients deemed unsuitable for inclusion in this study by the investigator.
Trial design
Treatments tested in this trial
- ABP1011T
Treatment groups
Sponsors and collaborators
Shanghai AB PharmaTech Ltd.
Lead sponsor
GCP ClinPlus Co., Ltd.
Collaborator