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.
Single group
TQB3454 tablets
DrugTQB3454 is a selective inhibitor of the IDH1 mutant enzyme.
Disease Control Rate (DCR)
The proportion of participants whose tumors shrank or remained stable for a certain period of time, including cases of CR, PR and SD, was determined by the researchers according to RANO/RECIST v1.1.
Progression-free survival (PFS)
The proportion of participants whose tumors shrank or remained stable for a certain period of time, including cases of CR, PR and SD, was determined by the researchers according to RANO/RECIST v1.1.
Secondary progression-free survival (PFS2)
It refers to the period from the start of enrollment and administration of the drug until the occurrence of objective disease progression again or death due to various reasons (whichever occurs first).
The 6-month progression-free survival rate
It refers to the proportion of participants who, from the time of enrollment and administration of the drug, until the 6th month, did not experience objective disease progression or death due to any reason (whichever occurred first).
Objective Response Rate(ORR)
The percentage of participants who achieved complete response (CR) or partial response (PR) as determined by RANO/RECIST1.1
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