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RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05313906
Collaborator
Rongchang Biopharmaceutical (Other), Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Other)
40
Enrollment
1
Location
1
Arm
23.8
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
RC48 plus AK105 and cisplatinRC48 plus AK105 and cisplatin
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
Anticipated Study Start Date :
May 7, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: exprimental group

RC48 plus AK105 and cisplatin

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

Outcome Measures

Primary Outcome Measures

  1. ORR [three months]

    the proportion of patients who got CR and PR

Secondary Outcome Measures

  1. PFS [six months and twelve months]

    the duration of diseases stable or better

  2. DCR [three months]

    the proportion of patients who got CR, PR and SD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university ZhengZhou Henan China 450008

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Quanli Gao, Dr, Henan Provincial Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Quanli Gao, Dr, Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05313906
Other Study ID Numbers:
  • HenanCH immunotherapy007
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms
Cisplatin

Study Results

No Results Posted as of Apr 6, 2022