A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

November 23, 2023 updated by: RemeGen Co., Ltd.

A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Herceptin as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Herceptin as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Herceptin as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lin Shen, PHD

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.
  • Age:18-70 years（including 18 and 70）.
  • Predicted survival ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Adequate organ function.
  • All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma.
  • Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence >6 months from completion of therapy are permitted;
  • HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+.

Exclusion Criteria:

  • Active central nervous system (CNS) metastases.
  • Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal.
  • Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RC48-ADC+Toripalimab+CAPOX
Participants with HER2 positive(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Drug: RC48-ADC
2.5 mg/kg IV every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Toripalimab
3.0 mg/kg IV every 2 weeks
Other Names:
  • JS001
Drug: Oxaliplatin injection
100mg/m2 Q3W
Other Names:
  • Oxaliplatin
Drug: Capecitabine
1000mg/m2 Q3W
Other Names:
  • Capecitabine Tablets
Experimental: RC48-ADC+Toripalimab+Herceptin
Participants with HER2 positive(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and Herceptin every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Drug: RC48-ADC
2.5 mg/kg IV every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Toripalimab
3.0 mg/kg IV every 2 weeks
Other Names:
  • JS001
Drug: Herceptin
First load dose is 8.0mg , then 6.0 mg/kg IV every 3 weeks
Other Names:
  • Trastuzumab
Experimental: RC48-ADC+Toripalimab+CAPOX(HER2-low)
Participants with HER2-low (IHC1+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Drug: RC48-ADC
2.5 mg/kg IV every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Toripalimab
3.0 mg/kg IV every 2 weeks
Other Names:
  • JS001
Drug: Oxaliplatin injection
100mg/m2 Q3W
Other Names:
  • Oxaliplatin
Drug: Capecitabine
1000mg/m2 Q3W
Other Names:
  • Capecitabine Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety(adverse event)
Time Frame: Up to approximately 2 years
to evaluate safety including adverse event rate and adverse event grade.
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR)
Time Frame: Up to approximately 2 years
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).
Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Time Frame: Up to approximately 2 years
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Up to approximately 2 years
Overall survival (OS)
Time Frame: Up to approximately 2 years
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Up to approximately 2 years
Duration of relief (DOR)
Time Frame: Up to approximately 2 years
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RemeGen Co., Ltd.

Investigators

  • Study Director: Na Su, PhD, RemeGen Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2023

Primary Completion (Estimated)

July 10, 2024

Study Completion (Estimated)

July 10, 2025

Study Registration Dates

First Submitted

July 1, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC48-C027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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