RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Gastric Cancer; Advanced Gastric Carcinoma
• Intervention / Treatment: Drug: RC48+AK105+cisplatin

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Quanli Gao, Dr; Phone Number: +8637165587795; Email: zlyygql0855@zzu.edu.cn

Study Locations

• China
  • Henan
    • ZhengZhou, Henan, China, 450008
      • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exprimental group; RC48 plus AK105 and cisplatin	Drug: RC48+AK105+cisplatin; RC48 plus AK105 and cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	the proportion of patients who got CR and PR	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	the duration of diseases stable or better	six months and twelve months
DCR	the proportion of patients who got CR, PR and SD	three months

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: Rongchang Biopharmaceutical; Zhengda Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Quanli Gao, Dr, Henan Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 7, 2022
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: HenanCH immunotherapy007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: The IPD will be shared with researhers who plan to do meta-analysis or other reasonable requests.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No