RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

NCT ID: NCT05313906

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-07
• Study Completion Date: 2024-04-30

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.

Conditions

Advanced Gastric Carcinoma; HER2-positive Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

exprimental group

RC48 plus AK105 and cisplatin

Group Type: EXPERIMENTAL

RC48+AK105+cisplatin

Intervention Type: DRUG

RC48 plus AK105 and cisplatin

Interventions

RC48+AK105+cisplatin

RC48 plus AK105 and cisplatin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rongchang Biopharmaceutical

UNKNOWN

Sponsor Role: collaborator

Zhengda Tianqing Pharmaceutical Group Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Quanli Gao

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quanli Gao, Dr

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial People's Hospital

Locations

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Countries

China

Central Contacts

Quanli Gao, Dr

Role: CONTACT

zlyygql0855@zzu.edu.cn

+8637165587795

Other Identifiers

HenanCH immunotherapy007

Identifier Type: -

Identifier Source: org_study_id