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Trial Title:
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
NCT ID:
NCT05980481
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Oxaliplatin
Trastuzumab
Disitamab vedotin
Conditions: Keywords:
RC48-ADC
HER2 expression
Gastric cancer
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC48-ADC
Description:
2.5 mg/kg intravenous infusion every 2 weeks
Arm group label:
RC48-ADC+Toripalimab+CAPOX
Arm group label:
RC48-ADC+Toripalimab+CAPOX(HER2-low)
Arm group label:
RC48-ADC+Toripalimab+Trastuzumab
Other name:
Disitamab Vedotin
Intervention type:
Drug
Intervention name:
Trastuzumab Injection
Description:
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Arm group label:
RC48-ADC+Toripalimab+Trastuzumab
Arm group label:
Toripalimab+Trastuzumab+CAPOX
Other name:
Trastuzumab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
3.0 mg/kg intravenous infusion every 2 weeks
Arm group label:
RC48-ADC+Toripalimab+CAPOX
Arm group label:
RC48-ADC+Toripalimab+CAPOX(HER2-low)
Arm group label:
RC48-ADC+Toripalimab+Trastuzumab
Arm group label:
Toripalimab+CAPOX(HER2-low)
Arm group label:
Toripalimab+Trastuzumab+CAPOX
Other name:
JS001
Intervention type:
Drug
Intervention name:
Oxaliplatin injection
Description:
130mg/m2 intravenous infusion Q3W
Arm group label:
RC48-ADC+Toripalimab+CAPOX
Arm group label:
RC48-ADC+Toripalimab+CAPOX(HER2-low)
Arm group label:
Toripalimab+CAPOX(HER2-low)
Arm group label:
Toripalimab+Trastuzumab+CAPOX
Other name:
Oxaliplatin
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2 per os Q3W
Arm group label:
RC48-ADC+Toripalimab+CAPOX
Arm group label:
RC48-ADC+Toripalimab+CAPOX(HER2-low)
Arm group label:
Toripalimab+CAPOX(HER2-low)
Arm group label:
Toripalimab+Trastuzumab+CAPOX
Other name:
Capecitabine Tablets
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.
Detailed 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+.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, PhD
Phone:
010-53806898
Email:
linshenpku@163.com
Start date:
August 4, 2023
Completion date:
July 10, 2025
Lead sponsor:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
RemeGen Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05980481
