Clinical trial NCT05735496: Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers
Official title: A Phase I Study of TQB2102 Injection in Patients 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: 2023-02-21
Enrollment: 226
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: TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB102 injection in subjects with advanced malignancies.


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 ≥12 weeks;
* Patients with advanced malignancies confirmed by cytology/histopathology, with priority given to those exhibiting HER2 expression, amplification, or mutation;
* Malignant tumor that failed from standard treatment or had no standard treatment;
* According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
* The main organs function well;
* Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to 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 3 years;
* History of uncontrolled intercurrent illness;
* Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
* Patients with known symptomatic brain metastases;
* Receiving any other investigational agent within 4 weeks before first dose;
* Patients with severe hypersensitivity after the use of monoclonal antibodies
* History of interstitial lung disease or pneumonia;
* 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: The occurrence rate of all adverse events (AEs)
timeFrame: From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
measure: Dose escalation: recommended phase 2 dose (RP2D)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Immunogenicity
timeFrame: Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days). 90 days after the end of the last infusion.
measure: Area under the curve (AUC)
timeFrame: Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days
measure: Peak concentration (Cmax)
timeFrame: Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days
measure: Terminal half-life (T1/2)
timeFrame: Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 day
measure: Objective Response Rate (ORR)
timeFrame: Baseline up to 2 years.
measure: Disease control rate (DCR)
timeFrame: Baseline up to 2 years.
measure: Duration of Response (DOR)
timeFrame: Baseline to the date of documented disease progression, up to 2 years.
measure: Progression-free survival (PFS)
timeFrame: Baseline to the date of documented disease progression, up to 2 years.
measure: Overall survival(OS)
timeFrame: Baseline to the date of death from any cause, up to 2 years.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital.
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital, Harbin, China
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
Study officials:
References: