Clinical trial NCT06649656: A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors
Official title: A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Cancers
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Adverse events (AE) rate
timeFrame: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.
Secondary outcomes:
measure: Time to reach maximum observed plasma concentration (Tmax)
timeFrame: 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)
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 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)
measure: Elimination half-life (t1/2)
timeFrame: 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)
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Progression-free survival (PFS)
timeFrame: up to 2 years
measure: Disease control rate (DCR)
timeFrame: up to 2 years
measure: Duration of Response (DOR)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong provincial people's hospital
state: Guangdong
Study officials:
References: