RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

Henan Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: HER2-positive Gastric Cancer; Advanced Gastric Carcinoma

Treatments: Drug: RC48+AK105+cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05313906

HenanCH immunotherapy007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

exprimental group

Experimental group

Description:

RC48 plus AK105 and cisplatin

Treatment:

Drug: RC48+AK105+cisplatin