HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    40
  • sponsor
    Shanghai Henlius Biotech
Updated on 16 May 2022

Summary

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Details
Condition Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Treatment HLX07, HLX07+HLX10+oxaliplatin+capecitabine
Clinical Study IdentifierNCT05246982
SponsorShanghai Henlius Biotech
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures
Age ≥ 18 years and ≤ 75 years when ICF is signed
Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma
Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines)
Measurable lesion according to RECIST v1.1 by IRRC
ECOG score 0-1
Expected survival 12 weeks

Exclusion Criteria

Has other active malignancies within 5 years before the first administration of the study drug
Plan to or have previously received organ or bone marrow transplantation
Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR
Have received any research drugs within 14 days before the first use of the study drugs
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How to participate?

Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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