Pancreatic Cancer
Conditions
Brief summary
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine \[AG\]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
Interventions
DRUGPlacebo for QLS31905
Placebo will be administered as an IV infusion.
DRUGQLS31905
QLS31905 will be administered as an IV infusion.
DRUGNab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion.
DRUGGemcitabine
Gemcitabine will be administered as an IV infusion.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 diagnosis of pancreatic cancer; * No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease; * 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Suryival(OS) | Up to 48 months | OS is defined as the time from randomization to deathdue to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 48 months | PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first). |
| Objective Response Rate (ORR) | Up to 48 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. Time Frame: Up to 48 months |
| Duration Of Response (DOR) | Up to 48 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). |
| Safety assessed by Adverse Events (AEs) | Up to 48 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. |
Countries
China
Contacts
Primary ContactLin Shen, M.D
Backup ContactJihui Hao, M.D
Outcome results
None listed