RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

Phase 2

• Conditions: Advanced Gastric Carcinoma; HER2-positive Gastric Cancer
• Interventions: Drug: RC48+AK105+cisplatin

• Registration Number: NCT05313906
• Lead Sponsor: Henan Cancer Hospital

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Study Start: 2022-05-07
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exprimental group	RC48+AK105+cisplatin	RC48 plus AK105 and cisplatin

Primary Outcome Measures

Name	Time	Method
ORR	three months	the proportion of patients who got CR and PR

Secondary Outcome Measures

Name	Time	Method
DCR	three months	the proportion of patients who got CR, PR and SD
PFS	six months and twelve months	the duration of diseases stable or better

Trial Locations

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university; 🇨🇳 ZhengZhou, Henan, China