A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.
1 other identifier
interventional
492
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJune 17, 2020
June 1, 2020
1.8 years
June 10, 2020
June 15, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0
Safety and tolerability (stage 1)
Up to 90 days from last dose
The percentages of participants discontinuing or suspending the study drug due to an AE.
Safety and tolerability (stage 1)
Up to 90 days from last dose
Overall survival（OS）（stage 2）
Overall survival is defined as time from randomization to death due to any cause.
from the date of first dose until the date of death from any cause,assessed up to 2 years
Secondary Outcomes (10)
Objective response rate（ORR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
up to 2 years
Disease control rate（DCR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
up to 2 years
Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
up to 2 years
Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
up to 2 years
Overall survival(stage 1)
from the date of first dose until the date of death from any cause,assessed up to 2 years
- +5 more secondary outcomes
Study Arms (3)
Experimental: Cohort A
EXPERIMENTALParticipants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.
Experimental: Cohort B-arm1
EXPERIMENTALParticipants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.
Experimental: Cohort B-arm2
EXPERIMENTALParticipants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Interventions
100mg/m2, D1,8,15,Q4w, IV infusion
Eligibility Criteria
You may qualify if:
- Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
- Age ≥ 18 years and ≤ 80 years when ICF is signed;
- Have histologically or cytologically confirmed diagnosis of locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma(G/GEJC).
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Life expectancy of at least 12 weeks;
- Have measurable disease as defined by RECIST 1.1 as determined by the investigator;
- Be willing to provide newly-obtained or paraffin-embedded tissue for PD-L1 and other biomarker analysis;
- HER-2/neu negative；
- 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;
- 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.
You may not qualify if:
- Has non-G/GEJC such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated gastric cancer;
- Known allergy or hypersensitivity to QL1604/nab-paclitaxel/paclitaxel or any components used in the preparation;
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease disease-relieving drugs, corticosteroids or immunosuppressant）;
- 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；
- 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;
- Has a known additional malignancy that is progressing or requires active treatment in past 3 years;
- Subjects with known central nervous system (CNS) metastasis;
- Has a history of pneumonitis that required steroids in past 3 years;
- Has an active infection requiring systemic therapy；
- Subjects with the history of Human Immunodeficiency Virus (HIV)、acquired, congenital immunodeficiency diseases、organ transplant;
- 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;
- Has received a live vaccine within 30 days of the planned start of study therapy；
- Has received prior immune checkpoint inhibitors;
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
- Subjects with uncontrollable cardiac diseases;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 2000 32, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 17, 2020
Study Start
July 1, 2020
Primary Completion
April 30, 2022
Study Completion
November 30, 2022
Last Updated
June 17, 2020
Record last verified: 2020-06