Clinical trial NCT05980481: A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
Official title: A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Keywords: RC48-ADC
HER2 expression
Gastric cancer
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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+.

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.

Primary outcomes:
measure: Objective remission rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Safety(adverse event)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS), evaluated by the investigator
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Duration of relief (DOR)
timeFrame: Up to approximately 2 years
measure: Disease Control Rate(DCR)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: RemeGen Co., Ltd.
name: Na Su, PhD
role: STUDY_DIRECTOR
References: