Clinical Trial Evaluating the Efficacy and Safety of TQB3454 Tablets in Participants With Advanced Solid Tumors

NCT07738679 | Not Yet Recruiting Phase 2

• 1 other identifier: TQB3454-II-01
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 48 weeks

Secondary Outcomes (9)

• Progression-free survival (PFS)

  up to 48 weeks

• Secondary progression-free survival (PFS2)

  up to 48 weeks

• The 6-month progression-free survival rate

  up to 6 months

• Objective Response Rate(ORR)

  up to 48 weeks

• Tumor Growth Rate (TGR)

  up to 48 weeks

Study Arms (1)

Treatment with TQB3454 tablets

EXPERIMENTAL

TQB3454 tablets, with a cycle of 28 days

Drug: TQB3454 tablets

Interventions

TQB3454 tablets DRUG

TQB3454 is a selective inhibitor of the IDH1 mutant enzyme.

Treatment with TQB3454 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Laboratory tests met the following criteria (within 14 days before screening, no blood transfusion, no use of hematopoietic stimulating drugs within 7 days for correction):
• \) Hemoglobin (HGB) ≥ 90 g/L; 2) Absolute neutrophil count (NEUT) ≥ 1.5×109/L; 3) Platelet count (PLT) ≥ 90×109/L; 4) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 5) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN. If accompanied by liver metastasis, ALT and AST ≤ 5 times ULN; 6) Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance rate (CCR) ≥ 50 ml/min; 7) Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant treatment within 2 weeks previously); (6) Participants agreed to provide tumor tissue specimens obtained through surgery or biopsy, and cohort 1 and cohort 2 were confirmed to carry IDH1 R132 gene mutation by molecular testing; cohort 3 was confirmed not to carry IDH1 R132 gene mutation by molecular testing; (7) Glioma and other advanced solid tumors confirmed by histological or cytological examination;
• For cohort 1 participants, they must meet:
• Diffuse glioma confirmed by histopathology (refer to the "WHO (Fifth Edition) Central Nervous System Tumor Classification"), and be patients with recurrence after surgery;
• The time from the last surgery to enrollment is greater than 4-6 weeks (including biopsy, surgical resection or other procedures entering the brain), and the surgical wound is judged to be healed well by the investigator;
• The dose of corticosteroid hormones was stable or gradually reduced within 5 days before administration;
• For cohort 2 participants (excluding cholangiocarcinoma):
• Locally advanced progressive/metastatic solid tumors confirmed by tissue and/or cell pathology.
• Standard treatment failure or no standard treatment available.
• For cohort 2 and cohort 3 participants with cholangiocarcinoma:
• Histologically or cytologically confirmed biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (iCCA; participants with mixed hepatocellular-cholangiocarcinoma where the cholangiocarcinoma component accounts for \>50%), perihilar cholangiocarcinoma (pCCA), distal cholangiocarcinoma (dCCA), and gallbladder carcinoma (GBC), presenting as unresectable locally advanced, recurrent, and/or metastatic disease.

You may not qualify if:

• 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.
• Participants with any Grade ≥3 bleeding event(s) per CTCAE v6.0 within 4 weeks prior to the first study drug administration.
• History of arterial or venous thromboembolic events within 6 months before the first dose.
• Uncontrolled active viral hepatitis.
• Active syphilis infection requiring therapeutic intervention.
• Presence of active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis requiring treatment, or symptomatic active pneumonia.
• History of illicit psychotropic substance abuse with no successful abstinence, or diagnosed psychiatric disorders.
• Planned or prior allogeneic bone marrow transplantation or solid organ transplantation.
• Medical history of hepatic encephalopathy.
• Diagnosis of severe cardiovascular disease defined as any of the following:
• New York Heart Association (NYHA) Class ≥II cardiac insufficiency, or echocardiography showing left ventricular ejection fraction (LVEF) \<50%; History of clinically significant ventricular arrhythmias, or arrhythmias requiring long-term antiarrhythmic medication; Unstable angina pectoris; Myocardial infarction occurring within the past 12 months; Fridericia-corrected QT interval (QTcF) \>450 milliseconds (msec) for male participants, \>470 msec for female participants; Personal or family history of congenital long QT syndrome; History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to enrollment and first dosing; Current use or recent use (within 7 days before study treatment initiation) of aspirin (\>325 mg/day, maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol.
• Active uncontrolled severe infection (Grade ≥2 infection per CTCAE v6.0).

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (22)

Sanbo Brain Hospital,Capital Medical University

Beijing, Beijing Municipality, 100018, China

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100032, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 101109, China

Location

The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, 730030, China

Location

Sun Yat-Sen Uuniversity Cancer Cerntr

Guangzhou, Guangdong, 510000, China

Location

AnYang Tumor Hospital

Anyang, Henan, 455001, China

Location

Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)

Luoyang, Henan, 471000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Zhengzhou University First Affiliated Hospital

Zhengzhou, Henan, 45002, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130033, China

Location

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, 110044, China

Location

The First Affiliated Hospital of Xi 'an Jiaotong University Medical College

Xi'an, Shaanxi, 710000, China

Location

Shandong Cancer Hosipital

Jinan, Shandong, 250117, China

Location

Shanghai Sixth People's Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200233, China

Location

The Second Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710000, China

Location

The Second Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710000, China

Location

SiChuan cancer hospital

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Central Study Contacts

Wenbin Li, Doctor

CONTACT

15301377998; neure55@126.com

Jiayong Liu, Doctor

CONTACT

13641103227; liujiayong@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-05

Locations

CN (22)