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RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Carcinoma, HER2-positive Gastric Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC48+AK105+cisplatin
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exprimental group

Arm Description

RC48 plus AK105 and cisplatin

Outcomes

Primary Outcome Measures

ORR
the proportion of patients who got CR and PR

Secondary Outcome Measures

PFS
the duration of diseases stable or better
DCR
the proportion of patients who got CR, PR and SD

Full Information

First Posted
March 29, 2022
Last Updated
March 29, 2022
Sponsor
Henan Cancer Hospital
Collaborators
Rongchang Biopharmaceutical, Zhengda Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05313906
Brief Title
RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer
Official Title
Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 7, 2022 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
Collaborators
Rongchang Biopharmaceutical, Zhengda Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Carcinoma, HER2-positive Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
RC48 plus AK105 and cisplatin
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exprimental group
Arm Type
Experimental
Arm Description
RC48 plus AK105 and cisplatin
Intervention Type
Drug
Intervention Name(s)
RC48+AK105+cisplatin
Intervention Description
RC48 plus AK105 and cisplatin
Primary Outcome Measure Information:
Title
ORR
Description
the proportion of patients who got CR and PR
Time Frame
three months
Secondary Outcome Measure Information:
Title
PFS
Description
the duration of diseases stable or better
Time Frame
six months and twelve months
Title
DCR
Description
the proportion of patients who got CR, PR and SD
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Others investigators evaluated not meet the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanli Gao, Dr
Phone
+8637165587795
Email
zlyygql0855@zzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quanli Gao, Dr
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
ZhengZhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

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