A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

Last updated: June 19, 2024
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

Oxaliplatin injection

Herceptin

Trastuzumab Injection

Clinical Study ID

NCT05980481
RC48-C027
  • Ages 18-70
  • All Genders

Study Summary

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.

  • Age:18-70 years（including 18 and 70）.

  • Predicted survival ≥ 12 weeks.

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

  • Adequate organ function.

  • All subjects must have inoperable, advanced or metastatic gastric or orgastroesophageal adenocarcinoma.

  • Subject must be previously untreated with systemic treatment; Subject that receivedneoadjuvant chemotherapy with recurrence >6 months from completion of therapy arepermitted;

  • HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+.

Exclusion

Exclusion Criteria:

  • Active central nervous system (CNS) metastases.

  • Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV)infection.

  • History of other malignancy within the previous 5 years, except for appropriatelytreated carcinoma in situ of the cervix, thyroid cancer ,etal.

  • Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of itscomponents.

  • Assessed by the investigator to be unable or unwilling to comply with therequirements of the protocol.

Study Design

Total Participants: 130
Treatment Group(s): 6
Primary Treatment: Oxaliplatin injection
Phase: 2/3
Study Start date:
August 04, 2023
Estimated Completion Date:
July 10, 2025

Study Description

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

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