A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma

November 28, 2023 updated by: CStone Pharmaceuticals

A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma

This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX) chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

479

Phase

  • 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 Locations

  • China
      • Beijing, China
        • Beijing 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years but ≤ 75 years
  2. Being able to follow the protocol requirements as per investigator's evaluation.
  3. Provide written informed consent before any protocol-related procedure (that is not a part of subject's routine care) is carried out.
  4. Unresectable locally advanced or metastatic gastric carcinoma (GC) or gastro-esophageal junction (GEJ) carcinoma, and have histologically confirmed predominant adenocarcinoma.
  5. The subject may have at least a measurable lesion or an evaluable lesion, if not measurable; the investigator will carry out evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to randomization.
  6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  7. Expected survival ≥ 3 months.
  8. Subject must not have received systemic treatment (including HER2 inhibitor) for advanced or metastatic gastric carcinoma.
  9. Subject must provide tumor tissue samples for biomarker analysis in order to determine the expression of PD-L1. According to central laboratory test, the PD-L1 expression is ≥ 5% in tumor tissue (including PD-L1 expression in tumor cells and tumor infiltrating immune cells).
  10. Permitted prior treatment: Subjects with GC or GEJ carcinoma priorly treated with adjuvant or neoadjuvant therapy, who experience clinical progression of disease at least 6 months after last dose are allowed to be enrolled.
  11. Subjects must have adequate organ function as assessed in the laboratory tests
  12. Subjects with active hepatitis B or active hepatitis C must receive antiviral treatment for at least 14 days prior to the first dose of study treatment and pass the hepatitis B virus (HBV) DNA titer test (≤ 500 IU/mL or 2500 copies/mL) and hepatitis C virus (HCV) RNA test (≤ lower limit of detection) before being enrolled. The subject should be willing to continue effective anti-viral treatment during the study.
  13. Female subject with childbearing potential must have negative serum pregnancy test result at screening, except for those with available sterilization operation record or post-menopausal subjects. Female subject with childbearing potential or male subjects and their partners must agree to take effective contraceptive measures from the day of signing ICF till at least 6 months after the last dosing of investigational product.

Exclusion Criteria:

  1. Known HER-2 positivity.
  2. A known additional primary malignancy that occurred within 5 years prior to the first dose of investigational treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  3. Known primary central nerve system (CNS) tumor or meningeal metastasis, or unstable CNS metastasis (symptomatic within 4 weeks before first dose of investigational product, requiring corticosteroid treatment, or without radiologic evidence supporting stable status for over 4 weeks prior to the first dose of investigational product).
  4. Any severe or uncontrolled systemic disease, for example diabetes mellitus or hypertension, that may increase the risk associated with participation or investigational product administration, or compromise subject's ability to receive investigational product, as per investigator's judgment.
  5. Known positive human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  6. Has had prior chemotherapy, immune therapy, biological therapy (including cancer vaccine, cytokine therapy or growth factors to control cancer) used as systemic treatment for cancer, within 14 days before the first dose of investigational product.
  7. Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins or immune checkpoints pathways(including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM3, anti-LAG3 antibody, etc.).
  8. Subjects with conditions that in the investigator's opinion are not suitable for participating in 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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CS1001 monoclonal antibody
in combination with Oxaliplatin and Capecitabine
Drug: CS1001 monoclonal antibody
Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
Drug: Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Drug: Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
Placebo Comparator: CS1001 placebo
in combination with Oxaliplatin and Capecitabine
Drug: Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Drug: Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
Drug: CS1001 placebo
Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months
from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months
Overall survival (OS)
Time Frame: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months
from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) evaluated by Blinded Independent Central Review Committee (BICR) according to RECIST v1.1
Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months
from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months
Objective response rate (ORR) evaluated by investigators according to RECIST v1.1
Time Frame: from the first dose of treatment until the best response, assessed up to 27 months
from the first dose of treatment until the best response, assessed up to 27 months
Duration of response (DOR) (evaluated by investigators according to RECIST v1.1)
Time Frame: from date of first documented objective response until first documented sign of disease progression or death due to any causes, whichever comes first, assessed up to approximately 27 months
from date of first documented objective response until first documented sign of disease progression or death due to any causes, whichever comes first, assessed up to approximately 27 months
Overall survival rate at 12 months and 24 months
Time Frame: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months
from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months
Evaluate the safety of CS1001 in combination with CAPOX chemotherapy compared to placebo in combination with CAPOX chemotherapy
Time Frame: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months
from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months

Collaborators and Investigators

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

Sponsor

CStone Pharmaceuticals

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 (Actual)

March 28, 2019

Primary Completion (Actual)

July 9, 2023

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1001-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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