RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

HER2-positive Gastric Cancer Clinical Trial

Official title:

Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05313906
• Other study ID #: HenanCH immunotherapy007
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 7, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2022
• Source: Henan Cancer Hospital
• Contact: Quanli Gao, Dr
• Phone: +8637165587795
• Email: zlyygql0855[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gastric Carcinoma
• HER2-positive Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• RC48+AK105+cisplatin
RC48 plus AK105 and cisplatin

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	ZhengZhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Rongchang Biopharmaceutical, Zhengda Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	the proportion of patients who got CR and PR	three months
Secondary	PFS	the duration of diseases stable or better	six months and twelve months
Secondary	DCR	the proportion of patients who got CR, PR and SD	three months