Advanced Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGQLS31905
Administered as an intravenous infusion.
DRUGOxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
DRUGCapecitabine
1000 mg/m2, oral, bid, D1-D14
DRUGGemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
DRUGCisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
DRUGQL1706
5 mg/kg, intravenous infusion,D1
DRUGChemotherapy drug
Standard chemotherapy recommended by guidelines.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects voluntarily participate in the study and sign the informed consent form; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; * Expected survival time ≥ 3 months; * Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors; * No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease; * Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC); * At least one measurable lesion per RECIST v1.1; * Patients with adequate cardiac, liver, renal function, etc.
Exclusion criteria
* History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ; * Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study; * Known central nervous system metastases; * Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; * Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Approximately 24 months | ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by incidence of serious adverse events (SAE) | Approximately 24 months | 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. |
| Number of participants with laboratory value abnormalities | Approximately 24 months | Number of participants with potentially clinically significant laboratory values. |
| Duration of Response (DOR) | Approximately 24 months | 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). |
| Progression Free Survival(PFS) | Approximately 24 months | 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). |
| Overall Survival (OS) | Approximately 24 months | 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. |
| Safety assessed by Adverse Events (AEs) | Approximately 24 months | 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 of the maximum concentration (Tmax) | Approximately 24 months | Tmax will be derived from the PK serum samples collected. |
| Terminal elimination half-life (T1/2) | Approximately 24 months | T1/2 will be derived from the PK serum samples collected. |
| Clearance (CL) | Approximately 24 months | CL will be derived from the PK serum samples collected. |
| Apparent volume of distribution during the terminal phase (Vz) | Approximately 24 months | Vz will be derived from the PK serum samples collected. |
| Number of anti-drug antibody (ADA) Positive Participants | Approximately 24 months | Immunogenicity will be measured by the number of participants that are ADA positive. |
| Maximum concentration (Cmax) | Approximately 24 months | Cmax will be derived from the PK serum samples collected. |
Countries
China
Outcome results
None listed