Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
NCT Number: NCT06585059
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).
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Guangzhou, Guangdong, 510060, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline up to 24 months
The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials).
Time frame: Up to 2 years
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Time frame: Up to 2 years
Defined as the time from first documented response to documented disease progression.
Time frame: Up to 2 years
Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.
Time frame: Up to 2 years
The time from randomization to obtaining the first objective relief.
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
The time required for plasma drug concentration to decrease by half.
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
The area enclosed by the plasma concentration curve against the timeline.
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent plasma clearance of TQB2928.
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
The ratio of the amount of TQB2928 in the body to the blood concentration.
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Minimum concentration during dosing.
Time frame: From the time of informed consent signed through 90 days after the last dose
Incidence of anti-drug antibody (ADA).
Time frame: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first
The occurrence and severity of all AEs.
Trial opening soon.
Get NotifiedChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Industry
A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07768358
Advanced Non-Small Cell Lung Cancer, Biliary Tract Diseases
View Trial DetailsNCT07392073
Adenocarcinoma, Adenocarcinoma of Lung
View Trial DetailsNCT07105176
Advanced Non-Small Cell Lung Cancer
Guangzhou, Guangdong, China
View Trial DetailsNCT06823245
Advanced Non-Small Cell Lung Cancer
View Trial Details