Clinical trial NCT04435652: A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.
Official title: A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel for Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.


Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years and ≤ 80 years when ICF is signed;
3. Have histologically or cytologically confirmed diagnosis of locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma(G/GEJC).
4. Eastern Cooperative Oncology Group performance status of 0 or 1;
5. Life expectancy of at least 12 weeks;
6. Have measurable disease as defined by RECIST 1.1 as determined by the investigator;
7. Be willing to provide newly-obtained or paraffin-embedded tissue for PD-L1 and other biomarker analysis;
8. HER-2/neu negative；
9. Female subjects of childbearing potential should have a negative serum human chorionic gonadotropin(HCG) test within 7 days prior to receiving the first dose of study medication and are not breastfeeding;
10. Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose.

Exclusion Criteria:

1. Has non-G/GEJC such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated gastric cancer;
2. Known allergy or hypersensitivity to QL1604/nab-paclitaxel/paclitaxel or any components used in the preparation;
3. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease disease-relieving drugs, corticosteroids or immunosuppressant）;
4. Has a diagnosis of immunodeficiency or received systemic steroid therapy （\>10mg daily of prednisone or equivalent drug）or any other form of immunosuppressive therapy within 14 days prior to the planned start of study therapy；
5. Subjects who have received radiotherapy, chemotherapy, monoclonal antibodies,targeted therapy, other anti-tumor treatments,or participating in other clinical studies is less than 4 weeks before the first dose of trial treatment;
6. Has a known additional malignancy that is progressing or requires active treatment in past 3 years;
7. Subjects with known central nervous system (CNS) metastasis;
8. Has a history of pneumonitis that required steroids in past 3 years;
9. Has an active infection requiring systemic therapy；
10. Subjects with the history of Human Immunodeficiency Virus (HIV)、acquired, congenital immunodeficiency diseases、organ transplant;
11. Has hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive and HBV deoxyribonucleic acid (HBV DNA) \>1000 copies/mL, or hepatitis C virus antibody positive;
12. Has received a live vaccine within 30 days of the planned start of study therapy；
13. Has received prior immune checkpoint inhibitors;
14. Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
15. Subjects with uncontrollable cardiac diseases;
16. Has accompanying diseases that seriously endanger the subject's safety or affect the study by the investigator;
17. Has any condition that increases the risk, interferes with the study results by the investigator, or investigators/sponsor consider the subjects are not suitable for this trial;

Primary outcomes:
measure: The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0
timeFrame: Up to 90 days from last dose
measure: The percentages of participants discontinuing or suspending the study drug due to an AE.
timeFrame: Up to 90 days from last dose
measure: Overall survival（OS）（stage 2）
timeFrame: from the date of first dose until the date of death from any cause,assessed up to 2 years
Secondary outcomes:
measure: Objective response rate（ORR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
timeFrame: up to 2 years
measure: Disease control rate（DCR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
timeFrame: up to 2 years
measure: Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
timeFrame: up to 2 years
measure: Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
timeFrame: up to 2 years
measure: Overall survival(stage 1)
timeFrame: from the date of first dose until the date of death from any cause,assessed up to 2 years
measure: Area under the concentration-time curve (AUC ) following single dose administration of PD-1（stage 1 ）
timeFrame: through study completion, an average of 2 years
measure: Peak plasma concentration (Cmax) following single dose administration of PD-1（stage 1 ）
timeFrame: through study completion, an average of 2 years
measure: Steady-state trough serum concentration of multiple Dose Administration of PD-1（stage 2）
timeFrame: through study completion, an average of 2 years
measure: Steady-state peak serum concentration of multiple Dose Administration of PD-1（stage 2）
timeFrame: through study completion, an average of 2 years
measure: Immunogenicity（stage 1 and 2）
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
References: