Advanced Solid TumorsPhase 2NCT07738679
Clinical Trial Evaluating the Efficacy and Safety of TQB3454 Tablets in Participants With Advanced Solid Tumors
A Phase 2 study testing TQB3454 tablets in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TQB3454 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 22 sitesChina
- Study dates
- Jul 2026to Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 1) 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;
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- 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.
- Prior disease progression after gemcitabine- or fluoropyrimidine-based therapy. (8) Pregnant women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the study ends. Male participants should agree to use effective contraceptive measures during the study period and within 6 months after the study ends.
Who cannot join
- 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.
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- 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).
- Renal failure requiring hemodialysis or peritoneal dialysis.
- History of immunodeficiency disorders, including HIV seropositivity or other acquired/congenital immunodeficiency diseases.
- Participants receiving immunosuppressive therapy, systemic hormones, or locally absorbable hormones for immunosuppressive purposes that must be continued within 7 days prior to the first dose (excluding glucocorticoids at a daily dose equivalent to <10 mg prednisone).
- Uncontrolled epilepsy.
- Tumor-related conditions and prior anticancer treatments:
- Participants who received chemotherapy or immunotherapy within 3 weeks before the first dose, radiotherapy or small-molecule targeted therapy within 2 weeks before the first dose, or those still within 5 half-lives of prior anticancer agents (whichever duration is shorter). The washout period is calculated from the date of last prior treatment.
- Received proprietary Chinese medicines with officially approved anti-tumor indications (per NMPA drug labeling) within 2 weeks prior to the first study drug administration.
- Imaging (CT or MRI) confirms tumor invasion into major blood vessels; or the Investigator judges that the tumor is highly likely to invade critical blood vessels during study treatment and cause life-threatening massive hemorrhage.
- Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites requiring repeated drainage (as assessed by the Investigator).
- Known spinal cord compression, leptomeningeal carcinomatosis, symptomatic brain metastases, or brain metastasis symptoms controlled for less than 4 weeks.
- Known hypersensitivity to any excipient component of the investigational product.
- Prior treatment with an IDH1 mutant inhibitor.
- Participation in another clinical trial involving investigational anti-tumor drugs within 4 weeks before the first study drug administration.
- Any condition judged by the Investigator to pose significant safety risks to the participant or interfere with the participant's ability to complete the study.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites
AnYang Tumor Hospital
Anyang, Henan, 455001
Chao Ren, Master, 13598104861, 617211299@qq.com
Sanbo Brain Hospital,Capital Medical University
Beijing, Beijing Municipality, 100018
Junping Zhang, Doctor, 13811099759, doczhjp@hotmail.com
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100032
Xinru Xiao, doctor, 13381279170, xrttyy2013@163.com
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Wenbin Li, Doctor, 15301377998, neure55@126.com
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jiayong Liu, Doctor, 13641103227, liujiayong@aliyun.com
Peking University People's Hospital
Beijing, Beijing Municipality, 101109
Lu Xie, Doctor, 13401044719, 5461843716@qq.com
The First Hospital of Jilin University
Changchun, Jilin, 130033
Jiuwei Cui, Doctor, 15843073215, jdyycjw@163.com
SiChuan cancer hospital
Chengdu, Sichuan, 610041
Haiqing Wang, Doctor, 13438983128, 541026814@qq.com
Sun Yat-Sen Uuniversity Cancer Cerntr
Guangzhou, Guangdong, 510000
Jin Wang, ph.D, 13600061066, wangjinr@sysucc.org.cn
Shandong Cancer Hosipital
Jinan, Shandong, 250117
ChangZheng LI, bachelor, 15553119057, Liczdoc@163.com
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, 730030
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000
Zhidong Pei, bachelor, 18537919398, Peizhidong2728@163.com
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
YongPing You, doctor, 025-68303147, YYPL3@sohu.com
Shanghai Sixth People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200233
HaiYan Hu, doctor, 18930174575, xuri1104@163.com
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, 110044
xiaojing zhang, doctor, 18900917416, zhangxiaojingwu@163.com
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jilong Yang, Doctor, 18622221626, yangjilong@tjmuch.com
The First Affiliated Hospital of Xi 'an Jiaotong University Medical College
Xi'an, Shaanxi, 710000
Aili Suo, Doctor, 18991232561, Ailisuo@mail.xjtu.edu.cn
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000
Liang Wang, Doctor, 13319232049, doctorwangliang@163.com
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000
Haichuan Su, Doctor, 18629190366, cntdgcp@163.com
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
Guihong Liu, Doctor, 18052268720, 2995181541@qq.com
Henan Cancer Hospital
Zhengzhou, Henan, 450008
JinXue Zhou, Doctor, 13837175001, zjx19882025@163.com
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, 45002
Wei He, doctor, 18638553286, hewei726@126.com
About this study
Official title: Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB3454 Tablets in Participants With Advanced Solid Tumors
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
- Being tested
- TQB3454 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3454 tabletsDrug
TQB3454 is a selective inhibitor of the IDH1 mutant enzyme.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with TQB3454 tablets | Experimental | TQB3454 tablets, with a cycle of 28 days Receives: Drug: TQB3454 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 weeks
Secondary outcomes (9)
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.
Measured: up to 48 weeks
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).
Measured: up to 48 weeks
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).
Measured: up to 6 months
Objective Response Rate(ORR)
The percentage of participants who achieved complete response (CR) or partial response (PR) as determined by RANO/RECIST1.1
Measured: up to 48 weeks
Tumor Growth Rate (TGR)
Defined as the percentage change in tumor size every 6 weeks during the treatment period
Measured: up to 48 weeks
Disease Remission Time (DOR)
From the first recorded objective response to the time of disease progression or death due to any cause (whichever occurs first), the duration was determined by the researchers according to RANO/RECIST v1.1.
Measured: up to 48 weeks
Overall Survival (OS)
It refers to the period of time from the start of enrollment to death due to various causes.
Measured: up to 2 years
The 12-month overall survival rate
It refers to the proportion of participants who did not experience any death due to various causes from the time of enrollment until the 12th month.
Measured: up to 12 months
The incidence and severity of adverse event
The severity is determined according to the NCI CTCAE v6.0 grading scale.
Measured: From the time when the participants signed the informed consent form until 30 days after the last medication administration / when they started a new anti-tumor treatment (whichever occurred first)，up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738679
- Sponsor's protocol ID
- TQB3454-II-01
- Status last verified
- May 2026
- First submitted
- 21 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No