Clinical trial NCT05894421: TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers
Official title: Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2223 Injection Combined With Penpulimab Injection in Subjects With Advanced Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: During the first treatment cycle (21 days).
measure: Maximum tolerated dose (MTD)
timeFrame: During the first treatment cycle (21 days).
measure: Objective Response Rate (ORR)
timeFrame: 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 outcomes:
measure: Percentage of anti-drug antibody (ADA) positive patients
timeFrame: Pre-dose on Cycle 1, 2, 4, 8 . 30 days and 90 days after the last dose. Each cycle is 21 days.
measure: The area under the curve (AUC)
timeFrame: 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.
measure: Peak concentration (Cmax)
timeFrame: 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.
measure: Terminal half-life (T1/2)
timeFrame: 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.
measure: Receptor occupation (RO)
timeFrame: 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.
measure: Objective Response Rate (ORR)
timeFrame: 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
measure: Disease control rate (DCR)
timeFrame: 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
measure: Duration of Response (DOR)
timeFrame: 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
measure: Progression-free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
measure: Number of patients with adverse events (AEs)
timeFrame: From the time of informed consent signed to 28 days after the last dose
measure: Number of patients with serious adverse events (SAEs)
timeFrame: From the time of informed consent signed to 28 days after the last dose
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Dalian
country: China
facility: The second hospital of Dalian medical university
state: Liaoning
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: