Solid Tumor
Conditions
Keywords
CLDN18.2, QLS31905
Brief summary
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Interventions
DRUGQLS31905
Administered as an intravenous infusion.
DRUGNab paclitaxel
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
DRUGGemcitabine
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
DRUGOxaliplatin
85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
DRUGCapecitabine
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
DRUGCisplatin
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
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 No maximum
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 have moderate-to-high Claudin18.2 expression 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 |
|---|---|---|
| Maximum Tolerated Dose (MTD) (Part A) | Approximately 12 months | As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort. |
| Phase 2 Recommended Dose（RP2D)(Part A) | Approximately 12 months | Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels. |
| Objective response rate (ORR)(Part B) | Approximately 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | Approximately 12 months | 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). |
| Duration Of Response (DOR) | Approximately 12 months | 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). |
| Overall Survival (OS) | Approximately 12 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. |
| Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax) | Approximately 12 months | Cmax will be derived from the PK serum samples collected. |
| Safety assessed by Adverse Events (AEs) | Approximately 12 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. |
| PK of QLS31905: Terminal elimination half-life (T1/2) | Approximately 12 months | T1/2 will be derived from the PK serum samples collected. |
| PK of QLS31905: Clearance (CL) | Approximately 12 months | CL will be derived from the PK serum samples collected. |
| PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz) | Approximately 12 months | Vz will be derived from the PK serum samples collected. |
| Number of anti-drug antibody (ADA) Positive Participants | Approximately 12 months | Immunogenicity will be measured by the number of participants that are ADA positive. |
| PK of QLS31905: Time of the maximum concentration (Tmax) | Approximately 12 months | Tmax will be derived from the PK serum samples collected. |
| Safety assessed by incidence of serious adverse events (SAE) | Approximately 12 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 and/or adverse events (AEs) | Approximately 12 months | Number of participants with potentially clinically significant laboratory values. |
Countries
China
Contacts
Primary ContactLin Shen, M.D
Outcome results
None listed