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

ConditionAdvanced Cancers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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；

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • TQB2252 injection

    Drug

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: TQB2252 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AE) rate

The evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0).

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 outcomes

1

Time to reach maximum observed plasma concentration (Tmax)

Time to reach maximum (peak) plasma concentration following drug administration

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)
2

Maximum Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration of TQB2252.

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)
3

Elimination half-life (t1/2)

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

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)
4

Objective Response Rate (ORR)

Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: