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

• Status: Recruiting
• Trial end date: 2025-07-10
• Target enrollment: 0
• Participant gender: All

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 Herceptin as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RemeGen Co., Ltd.
• Treatments: Capecitabine; Disitamab vedotin; Oxaliplatin; Trastuzumab

Criteria

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 or gastroesophageal adenocarcinoma.

• Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence >6 months from completion of therapy are permitted;

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

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 appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal.

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

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