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

NCT06649656 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB2252-I-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancers

Outcome Measures

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).

  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 (7)

• Time to reach maximum observed plasma concentration (Tmax)

  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)

  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)

  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)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

Study Arms (1)

TQB2252 injection

EXPERIMENTAL

This product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks.

Drug: TQB2252 injection

Interventions

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.

TQB2252 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.: lead

Study Sites (1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, 519041, China

Location

Central Study Contacts

Xing Zhang, Doctor

CONTACT

13610223691; zhangxing@sysucc.org.cn

Qingqing Cai, Doctor

CONTACT

13798101121; caiqq@sysucc.org.cn

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: October 17, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-06

Locations

CN (1)