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

NCT07338838 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB3142-I-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• Phase II recommended doses (RP2D)

  The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).

  Up to 24 months

• Dose-limiting toxicity (DLT)

  Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.

  Up to 1 month

• Maximum tolerated dose (MTD)

  The previous dose of the dose group in which dose-limiting toxicity occurs is the maximum tolerated dose.

  Up to 1 month

Secondary Outcomes (4)

• Numbers of participant with incidence and severity of Adverse Event (AE) and Serious Adverse Event (SAE), and abnormal laboratory test indicators

  Up to 24 months

• Peak time

  Up to 4 month

• Objective response rate

  Up to 24 months

• Peak concentration Cmax

  Up to 4 month

Study Arms (1)

TQB3142 injection

EXPERIMENTAL

The drug was administered every weeks for 28 consecutive days in a treatment cycle.

Drug: TQB3142 injection

Interventions

TQB3142 injection DRUG

TQB3142 for injection is a B-cell lymphoma-extra large inhibitor.

TQB3142 injection

Eligibility Criteria

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

You may qualify if:

• The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
• 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 measurable lesion according to RECIST 1.1 criteria；
• The main organs function well and meet the following criteria:
• Hemoglobin (HGB) ≥90g/L;
• Absolute neutrophil count (ANC) of solid tumor subjects ≥1.5×109 /L;
• Platelet count (PLT) ≥100×109/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:

Sponsors & Collaborators

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

Study Sites (2)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital , College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Central Study Contacts

Tong Yu Lin, Doctor

CONTACT

+86 13926400320; tongyulin@hotmail.com

Hong Yan Tong, Doctor

CONTACT

+86 13958122357; hongyantong@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2025-07

Locations

CN (2)