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Not yet recruiting NCT06649656

A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors

Phase I Interventional Advanced Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TQB2252 injection.
Who it may be relevant to
Registry conditions: Advanced Cancers. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.

Interventions

  • Drug TQB2252 injection
    TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle.

Primary outcome measures

  • Adverse events (AE) rate [Time frame: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.]
Secondary outcome measures (7)
  • Time to reach maximum observed plasma concentration (Tmax) [Time frame: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)]
  • Maximum Plasma Concentration (Cmax) [Time frame: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)]
  • Elimination half-life (t1/2) [Time frame: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)]
  • Objective Response Rate (ORR) [Time frame: up to 2 years]
  • Progression-free survival (PFS) [Time frame: up to 2 years]
  • Disease control rate (DCR) [Time frame: up to 2 years]
  • Duration of Response (DOR) [Time frame: up to 2 years]

Eligibility criteria

Inclusion criteria

  • The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
  • 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form);
  • Electrocorticogram (ECOG) score ranges from 0 to 1 points;
  • Expected survival is greater than 12 weeks；
  • Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria；
  • Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment；
  • Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period.

Exclusion criteria

  • Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication;
  • There are multiple factors that affect diseases related to intravenous injection and venous blood collection;
  • The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1;
  • Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication;
  • Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration;
  • An arterial/venous thrombotic event occurred within 6 months prior to the first administration;
  • Active viral hepatitis with poor control;
  • Active syphilis infected individuals in need of treatment;
  • History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;
  • Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
  • Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy;
  • Previously experienced grade 3 or higher adverse reactions related to immunotherapy;
  • Suffering from significant cardiovascular disease;
  • Active or uncontrolled severe infections;
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis;
  • History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
  • Individuals with epilepsy who require treatment;
  • Previously received treatment with similar anti-lag3 drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong provincial people's hospital — Guangzhou

Identifiers

NCT: NCT06649656 · TQB2252-I-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗