This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Administered as an intravenous infusion.
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Maximum Tolerated Dose (MTD) (Part A)
As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.
Time frame: Approximately 12 months
Phase 2 Recommended Dose（RP2D)(Part A)
Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.
Time frame: Approximately 12 months
Objective response rate (ORR)(Part B)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Time frame: Approximately 12 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 12 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 12 months
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
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85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Time frame: Approximately 12 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 progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Time frame: Approximately 12 months
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
Time frame: Approximately 12 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 12 months
Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax)
Cmax will be derived from the PK serum samples collected.
Time frame: Approximately 12 months
PK of QLS31905: Time of the maximum concentration (Tmax)
Tmax will be derived from the PK serum samples collected.
Time frame: Approximately 12 months
PK of QLS31905: Terminal elimination half-life (T1/2)
T1/2 will be derived from the PK serum samples collected.
Time frame: Approximately 12 months
PK of QLS31905: Clearance (CL)
CL will be derived from the PK serum samples collected.
Time frame: Approximately 12 months
PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz)
Vz will be derived from the PK serum samples collected.
Time frame: Approximately 12 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 12 months