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

Gastric Cancer Clinical Trial

Official title:

A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Herceptin as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980481
• Other study ID #: RC48-C027
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 4, 2023
• Est. completion date: July 10, 2025

Study information

• Verified date: August 2023
• Source: RemeGen Co., Ltd.
• Contact: Jian min Fang, PhD
• Phone: +86-010-58075561
• Email: jianminfang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Herceptin 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+.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 10, 2025
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• RC48-ADC
2.5 mg/kg IV every 2 weeks
• Herceptin
First load dose is 8.0mg , then 6.0 mg/kg IV every 3 weeks
• Toripalimab
3.0 mg/kg IV every 2 weeks
• Oxaliplatin injection
100mg/m2 Q3W
• Capecitabine
1000mg/m2 Q3W

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety(adverse event)	to evaluate safety including adverse event rate and adverse event grade.	Up to approximately 2 years
Secondary	Objective remission rate (ORR)	The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).	Up to approximately 2 years
Secondary	Progression-free survival (PFS), evaluated by the investigator	Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.	Up to approximately 2 years
Secondary	Overall survival (OS)	Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.	Up to approximately 2 years
Secondary	Duration of relief (DOR)	DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death	Up to approximately 2 years