RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Collaborators: Rongchang Biopharmaceutical; Zhengda Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Cisplatin

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