To Evaluate the Tolerability and Pharmacokinetics of TQB3142 for Injection in Patients With Advanced Malignant Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Malignant Tumors

In brief

To explore the safety, tolerability and pharmacokinetics of TQB3142 for injection in subjects with advanced malignant tumors

Key facts

Study ID

NCT07338838

Run by

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

People needed

66

Starts

2026-02-26

Expected to finish

2028-06-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
• 18 years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);
• Eastern Cooperative Oncology Group Performance Status (ECOG) score 0\~1;
• Expected survival greater than 12 weeks;
• Patients with advanced tumors confirmed by cytology/histopathology, failure of standard treatment or lack of effective treatment;
• Evidence of at least one evaluable lesion according to RECIST 1.1 criteria；
• The main organs function well and meet the following criteria:
• Hemoglobin (HGB) ≥80g/L (Patients with myeloid neoplasms must have hemoglobin level ≥ 60 g/L);
• Absolute neutrophil count (ANC) of solid tumor subjects ≥1.5×109 /L;
• Platelet count (PLT) ≥80×109/L (Patients with myeloid neoplasms must have a platelet count ≥ 30 × 10⁹/L)；
• Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);
• Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN. ALT and AST≤5×ULN if accompanied by liver metastasis;
• Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥60 mL /min (standard Cockcroft-Gault formula was applied;
• Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);
• Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

You may not qualify if…

• I. Comorbid Conditions and Medical History:
• Any active malignancy within the 3 years prior to the first dose, except for the specific cancer under study in this trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the lamina propria)], carcinoma in situ of the cervix, or carcinoma in situ of the breast).
• Failure to recover from toxicities and/or complications of prior interventions to ≤ Grade 1 per CTCAE, except for alopecia and peripheral neuropathy ≤ Grade 2.
• Receipt of any blood product transfusion or requirement for hematopoietic growth factor therapy within 28 days prior to the first dose.
• Bleeding Risk:
• Known bleeding diathesis or disorder.
• History of non-chemotherapy-induced thrombocytopenic bleeding or history of platelet transfusion refractoriness within 1 year prior to the first dose.
• Presence or high suspicion of active bleeding/hemolytic disorders such as Immune Thrombocytopenic Purpura (ITP), Autoimmune Hemolytic Anemia (AIHA), Evans Syndrome, Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura (TTP), Disseminated Intravascular Coagulation (DIC).
• Requirement for warfarin, aspirin, or other anticoagulant/antiplatelet agents for any reason within 28 days prior to treatment initiation.
• Uncontrolled or CTCAE ≥ Grade 2 bleeding events (e.g., gastrointestinal bleeding) or history of hemoptysis (> 2.5 mL of fresh blood per day) within 90 days prior to the first dose.
• Major surgical treatment or significant traumatic injury (excluding procedures like needle biopsy, endoscopic biopsy) within 28 days prior to the first dose.
• Non-healing wounds or fractures (excluding pathological fractures).
• Arterial/venous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
• History of drug (psychoactive substances) or alcohol abuse with inability to abstain, or presence of psychiatric disorders.
• Subjects with any severe and/or uncontrolled diseases, including:
• Poorly controlled blood pressure (systolic BP ≥ 150 mmHg or diastolic BP ≥ 100 mmHg) despite treatment with two or more antihypertensive medications.
• Myocardial ischemia or myocardial infarction ≥ Grade 2, arrhythmias, and congestive heart failure ≥ Grade 2 (NYHA classification).
• History or presence of non-infectious pneumonitis requiring corticosteroid treatment (including but not limited to Acute Respiratory Distress Syndrome, Acute Hypersensitivity Pneumonitis, Drug-Related Pneumonitis, Bronchospasm, Acute Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, etc.).
• History, presence, or suspicion of Chronic Obstructive Pulmonary Disease (COPD) with Forced Expiratory Volume in 1 second (FEV1) < 60% of predicted value.
• Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection).
• Diagnosis of Coronavirus Disease 2019 (COVID-19) infection within 3 months prior to the first dose.
• Decompensated cirrhosis (Child-Pugh class B or C), active hepatitis:
• Hepatitis B reference: Hepatitis B Virus (HBV) - DNA > 1*10³ copies/mL or >2000 IU/mL if HBsAg positive.
• Hepatitis C reference: Hepatitis C Virus (HCV) RNA above the upper limit of normal.
• (Note: Eligible subjects who are HBsAg positive or anti-Hepatitis B core (HBc) antigen positive, or have hepatitis C, require continuous antiviral therapy to prevent viral reactivation.)

Where it is running

• The First Affiliated Hospital , College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
• Guangzhou First Municipal People's Hospital — Guangzhou, Guangdong, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Sichuan Cancer Hospital — Chengdu, Sichuan, China
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China

Full record on ClinicalTrials.gov

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