TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers

Advanced Cancer Clinical Trial

Official title:

Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2223 Injection Combined With Penpulimab Injection in Subjects With Advanced Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894421
• Other study ID #: TQB2223-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: June 6, 2023
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Li Zhang, Doctor
• Phone: 86-020-87343458
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of TQB2223 injection in combination with Penpulimab in subjects with advanced cancers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;

• Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy =3 months;

• Histologically or cytologically confirmed malignancies;

• Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment;

• Patient has at least one evaluable lesion assessed by RECIST 1.1;

• The main organs function is well;

• Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures during study period until at least 6 months after the last dose of study drug.

Exclusion Criteria:

• Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;

• History of uncontrolled intercurrent illness;

• Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;

• Prior treatment targeting LAG-3;

• Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• TQB2223 injection+ Penpulimab Injection
TQB2223 is an anti lymphocyte activation gene-3 (LAG-3) antibody. Penpulimab Injection is an anti-PD-1 antibody.

Locations

Country	Name	City	State
China	The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The second hospital of Dalian medical university	Dalian	Liaoning
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)	DLT is defined as toxicities that meet pre-defined severity criteria of Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and assessed as having a suspected relationship to TQB2223 injection, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (21 days) of treatment.	During the first treatment cycle (21 days).
Primary	Maximum tolerated dose (MTD)	MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.	During the first treatment cycle (21 days).
Primary	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 and Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) for solid tumors, Lugano 2014 criteria and Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) for lymphoma.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.
Secondary	Percentage of anti-drug antibody (ADA) positive patients	Percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2223.	Pre-dose on Cycle 1, 2, 4, 8 . 30 days and 90 days after the last dose. Each cycle is 21 days.
Secondary	The area under the curve (AUC)	The area under the curve (AUC) of serum concentration of TQB2223	5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.
Secondary	Peak concentration (Cmax)	Maximum observed concentration (Cmax) of TQB2223	5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.
Secondary	Terminal half-life (T1/2)	The terminal elimination half-life (t 1/2) is the time that takes for the elimination processes to reduce the plasma concentration of the drug in the body by 50 %.	5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.
Secondary	Receptor occupation (RO)	Receptor occupation (RO) of LAG-3 after administration.	5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.
Secondary	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 and Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) for solid tumors, Lugano 2014 criteria and Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) for lymphoma.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Secondary	Disease control rate (DCR)	Defined as the proportion of subjects with CR, PR, or Stable Disease (SD).	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Secondary	Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression or death.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Secondary	Progression-free survival (PFS)	Defined as the time from the first dose of TQB2223 to the first occurrence of disease progression or death from any cause.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Secondary	Overall survival (OS)	Overall survival refers to the time from the first treatment to death from any cause.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Secondary	Number of patients with adverse events (AEs)	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From the time of informed consent signed to 28 days after the last dose
Secondary	Number of patients with serious adverse events (SAEs)	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From the time of informed consent signed to 28 days after the last dose