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

Phase

2/3

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

Capecitabine（750mg/m2）

Toripalimab

RC48-ADC（2.5mg/kg）

Clinical Study ID

NCT05980481

RC48-C027

Ages 18-75
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 or non-expression participants with locally advanced or metastatic gastric cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Voluntary agreement to provide written informed consent.
Age:18-75 years（including 18 and 75）.
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+ or IHC0.

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