This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Administered as an intravenous infusion.
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
1000 mg/m2, oral, bid, D1-D14
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)
Time frame: Approximately 24 months
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Time frame: Approximately 24 months
Safety assessed by incidence of serious adverse events (SAE)
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.
Time frame: Approximately 24 months
Number of participants with laboratory value abnormalities
Number of participants with potentially clinically significant laboratory values.
Time frame: Approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first).
Time frame: Approximately 24 months
Progression Free Survival(PFS)
PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first).
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1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
5 mg/kg, intravenous infusion,D1
Standard chemotherapy recommended by guidelines.
Time frame: Approximately 24 months
Overall Survival (OS)
OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.
Time frame: Approximately 24 months
Maximum concentration (Cmax)
Cmax will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
Time of the maximum concentration (Tmax)
Tmax will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
Terminal elimination half-life (T1/2)
T1/2 will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
Clearance (CL)
CL will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
Apparent volume of distribution during the terminal phase (Vz)
Vz will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Time frame: Approximately 24 months