A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.

June 15, 2020 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

492

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weijian Guo, Professor
  • Phone Number: 021-64175590

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 2000 32
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Cohort A
Participants 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.
3mg/kg, D1,8,15,Q4w, IV infusion
100mg/m2, D1,8,15,Q4w, IV infusion
Experimental: Experimental: Cohort B-arm1
Participants 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.
3mg/kg, D1,8,15,Q4w, IV infusion
100mg/m2, D1,8,15,Q4w, IV infusion
Experimental: Experimental: Cohort B-arm2
Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
80mg/m2, D1,8,15,Q4w, IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0
Time Frame: Up to 90 days from last dose
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.
Time Frame: Up to 90 days from last dose
Safety and tolerability (stage 1)
Up to 90 days from last dose
Overall survival(OS)(stage 2)
Time Frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Time Frame: up to 2 years
Objective response rate(ORR)assessed by the investigators according to RECIST 1.1.
up to 2 years
Disease control rate(DCR)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Time Frame: up to 2 years
Disease control rate(DCR)assessed by the investigators according to RECIST 1.1.
up to 2 years
Progression-free survival(PFS)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Time Frame: up to 2 years
Progression-free survival(PFS)assessed by the investigators according to RECIST 1.1.
up to 2 years
Tumor response rate(TRR)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Time Frame: up to 2 years
Tumor response rate(TRR)assessed by the investigators according to RECIST 1.1.
up to 2 years
Overall survival(stage 1)
Time Frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
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
Area under the concentration-time curve (AUC ) following single dose administration of PD-1(stage 1 )
Time Frame: through study completion, an average of 2 years
Area under the concentration-time curve (AUC ) following single dose administration of PD-1
through study completion, an average of 2 years
Peak plasma concentration (Cmax) following single dose administration of PD-1(stage 1 )
Time Frame: through study completion, an average of 2 years
Peak plasma concentration (Cmax) following single dose administration of PD-1
through study completion, an average of 2 years
Steady-state trough serum concentration of multiple Dose Administration of PD-1(stage 2)
Time Frame: through study completion, an average of 2 years
Steady-state trough serum concentrationof multiple Dose Administration of PD-1
through study completion, an average of 2 years
Steady-state peak serum concentration of multiple Dose Administration of PD-1(stage 2)
Time Frame: through study completion, an average of 2 years
Steady-state peak serum concentration of multiple Dose Administration of PD-1
through study completion, an average of 2 years
Immunogenicity(stage 1 and 2)
Time Frame: through study completion, an average of 2 years
The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • QL1604-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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