Advanced MalignanciesPhase 1NCT07730190
A Clinical Trial of TQB6426 for Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing TQB6426 for Injection in people with Advanced Malignancies, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 8 sites in China.
Trial summary
TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- TQB6426 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 8 sitesChina
- Study dates
- 25 Aug 2026to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Study participants voluntarily enroll in this study, sign the informed consent form, and demonstrate good treatment compliance.
- Age ranging from 18 to 75 years (calculated based on the date of informed consent signature).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated survival time exceeding 12 weeks.
- Child-Pugh liver function score ≤ 7 points (Class B).
- Per RECIST v1.1 criteria, at least one evaluable tumor lesion must be identified as a target lesion. Lesions previously treated with local therapy (transarterial embolization, transarterial chemoembolization, transarterial radioembolization, surgery, radiofrequency ablation, microwave ablation, other thermal ablation, percutaneous ethanol injection, radiotherapy, etc.) may also serve as target lesions provided there is documented progression in such lesions.
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- Participants must provide qualified tumor tissue specimens, or consent to submit archived tumor tissue samples, or undergo percutaneous core biopsy or surgical biopsy on previously unirradiated tumor lesions to supply specimens for central laboratory biomarker testing.
- Dose-escalation phase: Advanced solid tumors confirmed via histopathological or cytological examination with failure of prior standard systemic anti-tumor therapies.
- Dose-expansion phase: Glypican-3 (GPC3) positivity confirmed by immunohistochemistry (IHC); prior IHC test reports are acceptable.
- Hematology laboratory criteria (no blood transfusion/blood products or hematopoietic stimulating factor administration within 14 days prior to screening): Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- Serum biochemistry laboratory criteria: 1) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); for patients with intrahepatic metastases, ALT and AST ≤ 5 × ULN; 2) Total Bilirubin (TBIL) ≤ 3 × ULN (≤ 3 × ULN allowed for patients with Gilbert's syndrome); 3) Serum albumin ≥ 28 g/L; 4) Serum Creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL/min calculated via the Cockcroft-Gault formula.
- Urinalysis criteria: Urine protein < 2+ on routine urinalysis; if urine protein ≥ 2+, 24-hour urinary protein quantification must be confirmed ≤ 1.0 g.
- Coagulation function criteria: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤ 1.5 × ULN (for patients without prior anticoagulant therapy).
- Thyroid function criteria: Thyroid-Stimulating Hormone (TSH) ≤ ULN; participants with abnormal TSH but normal free T3 and free T4 levels are eligible for enrollment.
- Women of childbearing potential must agree to use effective contraception throughout the study and for 6 months after study completion, and have a negative serum pregnancy test within 7 days prior to enrollment. Male participants must agree to use effective contraception throughout the study and for 6 months following study completion.
Who cannot join
- Exclusion Criteria Subjects satisfying any of the following criteria shall be excluded from this trial: Prior treatment with GPC3-targeted agents or other antibody-drug conjugates (ADCs) utilizing topoisomerase I inhibitors as cytotoxic payloads.
- Diagnosis of another malignant tumor within 5 years prior to the first study dose, or concurrent secondary malignancy at screening. Eligible exceptions are as follows: other malignancies cured by single surgical resection with a continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, papillary thyroid carcinoma, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive carcinoma), Tis (carcinoma in situ), T1 (tumor invading lamina propria)].
- Medical conditions interfering with intravenous injection or venous blood collection (including but not limited to active phlebitis, severe lymphedema, extensive cutaneous infection, etc.).
- Unresolved adverse toxicities higher than NCI CTCAE Grade 1 stemming from prior therapies, excluding alopecia, skin pigmentation, and toxicities deemed by the Investigator to carry no safety risks.
- Major surgical procedures, significant traumatic injuries within 4 weeks before the first dose, or persistent unhealed wounds/fractures.
- Any hemorrhagic event ≥ NCI CTCAE Grade 3 occurring within 4 weeks prior to the first administration of study drug.
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- History of arterial or venous thromboembolic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism. (Note: Thrombosis related to implantable venous access ports, catheter-induced thrombosis, or superficial venous thrombosis shall not be categorized as "severe" thromboembolism.)
- Participants with active viral hepatitis and poor disease control are excluded. Participants meeting the following criteria may be screened: HBsAg-positive participants must have a quantitative HBV DNA level <2000 IU/mL (or 10000 copies/mL), and participants shall receive anti-HBV therapy throughout the entire study period. Participants with HCV infection requiring treatment may receive approved antiviral therapy during the study.
- Imaging confirmation of inferior vena cava tumor thrombus, complete occlusion of the main portal vein (tumor thrombus or blood thrombus), concurrent tumor thrombus invasion of the main portal vein plus primary branches, or portal vein tumor thrombus extending into the superior mesenteric vein, splenic vein or more proximal vessels.
- Peptic ulcer disease or inflammatory bowel disease.
- Active syphilis infection requiring clinical treatment.
- Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis/radiation pneumonitis requiring treatment, symptomatic active pneumonia; prior interstitial lung disease (ILD) that required intervention or current ILD.
- History of untreatable psychoactive substance abuse or diagnosed psychiatric disorders.
- Candidates scheduled for allogeneic bone marrow transplantation or solid organ transplantation, or those who have received such transplantations previously.
- Documented history of hepatic encephalopathy.
- Subjects with any severe and/or uncontrolled underlying diseases, including:
- 1) Uncontrolled hypertension (systolic BP ≥ 150 mmHg or diastolic BP ≥ 100 mmHg); 2) Poorly managed cardiac symptoms or disorders: a. Myocardial ischemia or myocardial infarction ≥ Grade 2, congestive heart failure ≥ NYHA Class II; b. Myocardial infarction within the past 12 months; c. Arrhythmias: Fridericia-corrected QT interval (QTcF) > 450 msec in males and > 470 msec in females. If QTcF is abnormal, three serial measurements separated by at least 2 minutes shall be performed and the average value adopted; frequent ventricular premature contractions, significant sinus bradycardia, or other conditions assessed by the Investigator and relevant departments to confer high risk of malignant arrhythmia, or other conditions judged by the Investigator to predispose to malignant arrhythmia.
- 3) Active or uncontrolled severe infections (≥ NCI CTCAE Grade 2 infection); 4) Evidence of bleeding diathesis or severe coagulopathy; 5) Current or recent use (within 10 days prior to first study treatment) of aspirin (>325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, or other anticoagulant/antiplatelet agents; 6) Renal failure requiring hemodialysis or peritoneal dialysis; 7) History of immunodeficiency, including HIV positivity or other acquired/congenital immunodeficiency disorders; 8) Subjects requiring immunosuppressants, systemic hormones, or absorbable topical hormones for immunosuppressive purposes and continuing such treatment within 7 days before the first dose (excluding glucocorticoids at a daily dose equivalent to <10 mg prednisone); 9) Diagnosed epilepsy requiring ongoing treatment; 10) Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L); 11) History of gastrointestinal hemorrhage within 6 months before the first dose; portal hypertension with high bleeding risk as assessed by the Investigator, or positive red color sign on gastroscopy.
- Tumor-related symptoms and prior anti-tumor therapies:
- Subjects who received chemotherapy or immunotherapy within 2 weeks before the first dose, endovascular interventional therapy, local ablation, radiotherapy or small-molecule targeted agents within 2 weeks before the first dose, or remain within 5 half-lives of the last administered drug (the shorter time frame shall prevail). The washout period shall be calculated from the date of completion of the last prior anti-tumor treatment.
- Treatment with Chinese patent medicines with anti-tumor indications clearly stated in NMPA-approved labeling within 2 weeks before the first dose (including Compound Mylabris Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea Javanica Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.).
- CT/MRI imaging showing tumor invasion into major blood vessels, or tumors assessed by the Investigator to have high risk of invading critical vessels and triggering fatal massive hemorrhage during the trial (e.g., tumors adjacent to or encasing the pulmonary artery or aorta).
- Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites requiring repeated drainage.
- Severe biliary obstruction (excluding subjects with total bilirubin ≤ 2 × ULN after endoscopic stenting, percutaneous transhepatic biliary drainage or other interventions).
- Confirmed spinal cord compression, pathological fractures of weight-bearing bones, extensive bone metastases, or intractable tumor-related bone pain.
- Carcinomatous meningitis, symptomatic brain metastases, or brain metastases with symptom control lasting less than 4 weeks. 8) Spontaneous tumor rupture or high risk of impending tumor rupture.
- Known hypersensitivity to the study drug or its excipients. (19) Participation in another clinical trial of anti-tumor investigational products with study drug administration within 4 weeks before the first dose.
- Lactating female subjects. (21) Any condition judged by the Investigator to pose substantial safety risks to the subject or impair the subject's ability to complete the trial.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yuan Cheng, Doctor, 13811659696, softsnake@bjmu.edu.cn
Xia Zhao, Doctor, 13621020878, zxyjk@126.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, Doctor, 13873123436, zhangyongchang@csu.edu.cn
- Not yet recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Jie Shen, Doctor, 15922318586, 5845348@qq.com
Yifeng Tian, Doctor, 13003833861, tianyifengfz@163.com
- Not yet recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Jian Zhang, Doctor, 13925091863, blacktiger@139.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng, Doctor, 15134569619, zhengtongsen@126.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yufeng Gao, Doctor, 13956938032, aygyf@126.com
Huan Zhou, Doctor, 13665527160, zhouhuanbest@vip.163.com
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Qiang Xia, Doctor, 13661889035, Xiaqiang@medmail.com.cn
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Jinxue Zhou, Doctor, 13837175001, Zhoujx888@126.com
Yanqiu Zhao, Doctor, 13938252350, 13938252350@163.com
About this study
Official title: A Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB6426 for Injection in Patients With Advanced Malignancies
TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.
- Conditions
- Advanced Malignancies
- Being tested
- TQB6426 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB6426 for InjectionDrug
TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| TQB6426 Dose Escalation and Expansion | Experimental | This arm includes two phases:
Dose Escalation Phase (Phase Ia): Treatment regimen is TQB6426 for Injection via intravenous infusion (IV) on Day 1, every 3 weeks (Q3W). An accelerated titration design combined with a "Rolling 6" dose-escalation approach was adopted.
Dose Expansion Phase (Phase Ib): The study dose will be finalized according to the results from Phase Ia, administered intravenously on Day 1 every 3 weeks (Q3W). Receives: Drug: TQB6426 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Study participants experienced protocol-specified adverse events related to the investigational drug within one cycle (21 days) of receiving the investigational drug.
Measured: Baseline to 21 days
Maximum Tolerated Dose
The highest dose at which less than 33% of study participants experience dose-limiting toxicity (DLT)
Measured: Baseline to the end of the first treatment cycle (each cycle is 21 days）
Recommended Phase II Dose
The dose level of TQB6426 recommended for the further clinical trail studies based on assessment of the safety, efficacy and PK data from this study.
Measured: Baseline to study completion (up to 24 months).
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs)
Measured: up to 24 months
Maximum Administered Dose
MAD is defined to be reached if, following the pre-specified dose escalation, a dose-exposure plateau is achieved as judged by PK data, or further dose escalation carries substantial safety risks or subjects cannot tolerate continued dose increase based on available safety data, or model analysis indicates that the optimal safe and effective target dose has been explored.
Measured: Baseline to the end of the first treatment cycle (each cycle is 21 days）
Secondary outcomes (15)
Maximum Concentration (Cmax)
Cmax refers to the maximum drug concentration in plasma after administration.
Measured: up to 24 months
Area under the plasma drug concentration-time curve from time zero to the time of the last accurately quantifiable concentration (AUC0-t)
AUC0-t refers to the total systemic exposure to the drug from the time of administration until the last accurately quantifiable concentration is observed.
Measured: up to 24 months
Area under the plasma concentration-time curve extrapolated from time zero to infinite time（AUC0-∞）
AUC0-∞ refers to the total systemic exposure to the drug from the time of administration to infinite time .
Measured: up to 24 months
Time to peak concentration (Tmax)
The time from drug administration to the time point of the maximum observed plasma drug concentration.
Measured: up to 24 months
Terminal Elimination Rate Constant（λz）
First-order rate constant governing the elimination of drug from plasma during the terminal log-linear elimination phase.
Measured: up to 24 months
Terminal Elimination Half-Life (t1/2)
The time required for the plasma drug concentration to decrease by one-half during the terminal elimination phase.
Measured: up to 24 months
Apparent Clearance (CL)
Apparent clearance following extravascular administration, calculated as Dose / AUC0-∞
Measured: up to 24 months
Apparent Volume of Distribution (Vd)
Volume of Distribution (Vd) is a pharmacokinetic parameter that refers to the ratio of the total amount of drug in the body to its plasma concentration when the drug reaches a dynamic equilibrium in the body.
Measured: up to 24 months
Percentage of extrapolated AUC0-∞ (%AUCextrap)
The percentage of AUC0-∞ extrapolated refers to the percentage of the area extrapolated from the last accurately quantifiable concentration to infinity (AUCextrap) relative to the total AUC0-∞. It is used to evaluate the reliability of the AUC0-∞ estimation.
Measured: up to 24 months
Incidence of anti-drug antibodies (ADAs)
Anti-drug antibodies (ADAs) are immune system-produced antibodies that specifically bind to therapeutic drugs (especially biologics or monoclonal antibodies). The development of ADAs can alter the drug's pharmacokinetics, reduce its clinical efficacy, or cause safety issues such as hypersensitivity reactions.
Measured: up to 24 months
Objective Response Rate（ORR）
The proportion of subjects with confirmed complete response (CR) or partial response (PR).
Measured: up to 24 months
Duration of Response （DOR）
The time from the date of first confirmed complete response (CR) or partial response (PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.
Measured: up to 24 months
Disease Control Rate（DCR）
The proportion of subjects achieving complete response, partial response or stable disease.
Measured: up to 24 months
Progression-Free Survival （PFS）
The time from the first dose of study drug to the date of first documented disease progression or death from any cause, whichever occurs first.
Measured: up to 24 months
Overall Survival（OS）
The time from first dose of study drug to date of death from any cause.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start25 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730190
- Sponsor's protocol ID
- TQB6426-I-01
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB6426 for Injection in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT07730190
- Acronym / sponsor ID
- TQB6426-I-01
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB6426 Dose Escalation and Expansion | Experimental | Drug: TQB6426 for InjectionThis arm includes two phases: Dose Escalation Phase (Phase Ia): Treatment regimen is TQB6426 for Injection via intravenous infusion (IV) on Day 1, every 3 weeks (Q3W). An accelerated titration design combined with a "Rolling 6" dose-escalation approach was adopted. Dose Expansion Phase (Phase Ib): The study dose will be finalized according to the results from Phase Ia, administered intravenously on Day 1 every 3 weeks (Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Study participants voluntarily enroll in this study, sign the informed consent form, and demonstrate good treatment compliance.
- Age ranging from 18 to 75 years (calculated based on the date of informed consent signature).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated survival time exceeding 12 weeks.
- Child-Pugh liver function score ≤ 7 points (Class B).
Key exclusion criteria (28 listed)
- Exclusion Criteria Subjects satisfying any of the following criteria shall be excluded from this trial: Prior treatment with GPC3-targeted agents or other antibody-drug conjugates (ADCs) utilizing topoisomerase I inhibitors as cytotoxic payloads.
- Diagnosis of another malignant tumor within 5 years prior to the first study dose, or concurrent secondary malignancy at screening. Eligible exceptions are as follows: other malignancies cured by single surgical resection with a continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, papillary thyroid carcinoma, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive carcinoma), Tis (carcinoma in situ), T1 (tumor invading lamina propria)].
- Medical conditions interfering with intravenous injection or venous blood collection (including but not limited to active phlebitis, severe lymphedema, extensive cutaneous infection, etc.).
- Unresolved adverse toxicities higher than NCI CTCAE Grade 1 stemming from prior therapies, excluding alopecia, skin pigmentation, and toxicities deemed by the Investigator to carry no safety risks.
- Major surgical procedures, significant traumatic injuries within 4 weeks before the first dose, or persistent unhealed wounds/fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB6426 for InjectionTQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials. | Drug | TQB6426 Dose Escalation and Expansion |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: Baseline to 21 days
Study participants experienced protocol-specified adverse events related to the investigational drug within one cycle (21 days) of receiving the investigational drug.
Maximum Tolerated Dose
Time frame: Baseline to the end of the first treatment cycle (each cycle is 21 days）
The highest dose at which less than 33% of study participants experience dose-limiting toxicity (DLT)
Recommended Phase II Dose
Time frame: Baseline to study completion (up to 24 months).
The dose level of TQB6426 recommended for the further clinical trail studies based on assessment of the safety, efficacy and PK data from this study.
Incidence and severity of adverse events (AEs)
Time frame: up to 24 months
Incidence and severity of adverse events (AEs)
Maximum Administered Dose
Time frame: Baseline to the end of the first treatment cycle (each cycle is 21 days）
MAD is defined to be reached if, following the pre-specified dose escalation, a dose-exposure plateau is achieved as judged by PK data, or further dose escalation carries substantial safety risks or subjects cannot tolerate continued dose increase based on available safety data, or model analysis indicates that the optimal safe and effective target dose has been explored.
15 secondary outcomes
Maximum Concentration (Cmax)
Time frame: up to 24 months
Area under the plasma drug concentration-time curve from time zero to the time of the last accurately quantifiable concentration (AUC0-t)
Time frame: up to 24 months
Area under the plasma concentration-time curve extrapolated from time zero to infinite time（AUC0-∞）
Time frame: up to 24 months
Time to peak concentration (Tmax)
Time frame: up to 24 months
Terminal Elimination Rate Constant（λz）
Time frame: up to 24 months
Terminal Elimination Half-Life (t1/2)
Time frame: up to 24 months
Apparent Clearance (CL)
Time frame: up to 24 months
Apparent Volume of Distribution (Vd)
Time frame: up to 24 months
Percentage of extrapolated AUC0-∞ (%AUCextrap)
Time frame: up to 24 months
Incidence of anti-drug antibodies (ADAs)
Time frame: up to 24 months
Objective Response Rate（ORR）
Time frame: up to 24 months
Duration of Response （DOR）
Time frame: up to 24 months
Disease Control Rate（DCR）
Time frame: up to 24 months
Progression-Free Survival （PFS）
Time frame: up to 24 months
Overall Survival（OS）
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB6426 for Injection in people with Advanced Malignancies, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Xia, Doctor (13661889035, Xiaqiang@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: Baseline to 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.