RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

NCT05313906 | Unknown Phase 2

• 1 other identifier: HenanCH immunotherapy007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Carcinoma; HER2-positive Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  the proportion of patients who got CR and PR

  three months

Secondary Outcomes (2)

• PFS

  six months and twelve months

• DCR

  three months

Study Arms (1)

exprimental group

EXPERIMENTAL

RC48 plus AK105 and cisplatin

Drug: RC48+AK105+cisplatin

Interventions

RC48+AK105+cisplatin DRUG

RC48 plus AK105 and cisplatin

exprimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Rongchang Biopharmaceutical: collaborator
• Zhengda Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

Location

Study Officials

• Quanli Gao, Dr

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanli Gao, Dr

CONTACT

+8637165587795; zlyygql0855@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: RC48 plus AK105 and cisplatin

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: May 7, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: The IPD will be shared with researhers who plan to do meta-analysis or other reasonable requests.

Locations

CN (1)