Clinical trial NCT05313906: RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer
Official title: Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Gastric Carcinoma
HER2-positive Gastric Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Rongchang Biopharmaceutical
name: Zhengda Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2022-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: RC48 plus AK105 and cisplatin
Primary purpose: TREATMENT

Brief summary: To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.

Detailed description: Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old, ≤75 years old, regardless gender
* Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+
* ECOG PS scores 0-1
* Stage IV according to AJCC 8.0 and no systemic therapy previously
* Expected lifespan ≥ 3 months
* Adequate organ function
* At least one measurable lesion according to RECIST 1.1
* Asymptomatic intracranial metastasis
* No history of other malignancies
* Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial
* Agreed to participate in this clinical study and signed the Informed Consent

Exclusion Criteria:

* Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose
* Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor
* Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration
* Active autoimmune diseases or immunodeficiency diseases
* Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug
* Severe mental disorder
* Receiving systemic corticosteroids within 7 days prior to the first dose of the study
* Clinically apparent cardiovascular and cerebrovascular disease
* Others investigators evaluated not meet the inclusion criteria

Primary outcomes:
measure: ORR
timeFrame: three months
Secondary outcomes:
measure: PFS
timeFrame: six months and twelve months
measure: DCR
timeFrame: three months
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Quanli Gao, Dr
role: PRINCIPAL_INVESTIGATOR
References: