This is a multicenter phase II study designed to evaluate the efficacy and safety of TQB3454 as monotherapy in patients with advanced solid tumors, divided into three cohorts.Cohort 1: Enrolled patients with diffuse glioma harbouring IDH1 R132 mutations. Cohort 2: Enrolled patients with advanced solid tumours (excluding glioma) harbouring IDH1 R132 mutations who failed standard therapy. Cohort 3: Enrolled patients with locally advanced, recurrent and/or metastatic biliary tract cancer without IDH1 mutations who progressed after gemcitabine or fluoropyrimidine-based treatment.
Participants voluntarily joined this study and signed the informed consent form, showing good compliance;
Age 18 years or above and 75 years or below (calculated based on the date of signing the informed consent form);
Karnofsky Performance Status(KPS) score ≥ 60 points (for the first cohort), Eastern Cooperative Oncology Group(ECOG) score 0-1 point (for the second and third cohorts);
Patients in Cohort 1 must have at least one radiographically measurable tumour lesion confirmed by magnetic resonance imaging (MRI) in two perpendicular dimensions per the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.Patients in Cohort 2 and Cohort 3 are required to have at least one measurable lesion in accordance with the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1).
Participants who have a history of other malignancies within 3 years prior to the first study drug administration, or who are concurrently diagnosed with other malignancies at screening.
Presence of diseases interfering with intravenous infusion or venipuncture; or multiple factors impairing oral drug intake (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
Adverse reactions from prior anticancer therapies that have not recovered to Grade ≤1 per CTCAE v6.0.
Participants who received major surgical procedures or significant traumatic injuries within 4 weeks before the first dose, or those who are expected to undergo major surgery during the study treatment period (excluding surgeries specified in the protocol); or participants with unhealed wounds or fractures.