Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Location contact
Li Zhang, Doctor
CONTACT
Wenfeng Fang, Doctor
CONTACT
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
Li Zhang, Doctor
CONTACT
Wenfeng Fang, Doctor
CONTACT
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.
Contact information is provided by the study sponsor or research team.
Li Zhang, Doctor
CONTACT
Wenfeng Fang, Doctor
CONTACT
Chia 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.
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