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Clinical Trials in China / NCT06585059
Starting soon Phase 1

Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers

NCT06585059 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2024-09
Last updated
2024-09-05

Condition(s) studied

Advanced Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

TQB2928 injection + Almonertinib Mesilate Tablets

TQB2928 injection + Almonertinib Mesilate Tablets: TQB2928 is a recombinant fully humanized Immunoglobulin G4 (IgG4) monoclonal antibody that can promote tumor cell phagocytosis by macrophages and exert anti-tumor effects. Almonertinib Mesilate Tablets is a third generation of EGFR-TKI targeting drug.

Study summary

This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months; * Locally advanced or metastatic NSCLC diagnosed by histology or cytology * The major organs are functioning well; * Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study; * Subjects voluntarily joined this study, signed the informed consent form, and had good compliance. Exclusion Criteria: * Current concomitant presence of other malignancies within 5 years prior to the first dose; * Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy; * Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose; * Long-term unhealed wounds or fractures; * Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose; * A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; * Subjects with any severe and/or uncontrolled disease; * History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study; * Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations; * According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06585059 on ClinicalTrials.gov ↗ ← All trials in China