SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Last updated: December 11, 2024
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Adenocarcinoma

Esophageal Disorders

Digestive System Neoplasms

Treatment

SHR-A1904

Paclitaxel, Docetaxel, Irinotecan

Clinical Study ID

NCT06649292
SHR-A1904-302
  • Ages 18-75
  • All Genders

Study Summary

The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 to 75 years old (including boundary values)

  2. Volunteer to participate in this clinical study and sign informed consent;

  3. ECOG score 0-1;

  4. Expected survival ≥3 months;

  5. Gastric or Gastroesophageal Junction Adenocarcinoma;

  6. positive CLDN18.2 expression in tumor tissue;

  7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1criteria;

  8. Adequate bone marrow and organ function.

Exclusion

Exclusion Criteria:

  1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biologicaltherapy, targeted therapy, or immunotherapy within 4 weeks before the first dose ofthe study

  2. HER2 posotive (IHC 3+ or IHC 2+/ISH +);

  3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0Grade≤1;

  4. Individuals with Leptomeningeal metastasis or Active brain metastases;

  5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;

  6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;

  7. The researcher determined that there are other situations that are not suitable forparticipation.

Study Design

Total Participants: 524
Treatment Group(s): 2
Primary Treatment: SHR-A1904
Phase: 3
Study Start date:
November 22, 2024
Estimated Completion Date:
March 20, 2028

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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