NCT07338838
Not yet recruiting
Phase 1
A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TQB3142 for Injection in Patients With Advanced Malignant Tumors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 sites in 1 country66 target enrollmentStarted: January 1, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Phase II recommended doses (RP2D)
Overview
Brief Summary
To explore the safety, tolerability and pharmacokinetics of TQB3142 for injection in subjects with advanced malignant tumors
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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；
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Phase II recommended doses (RP2D)
Time Frame: Up to 24 months
The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).
Dose-limiting toxicity (DLT)
Time Frame: Up to 1 month
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.
Maximum tolerated dose (MTD)
Time Frame: Up to 1 month
The previous dose of the dose group in which dose-limiting toxicity occurs is the maximum tolerated dose.
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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