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

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

RC48-ADC

Herceptin

Toripalimab

Oxaliplatin injection

Capecitabine

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring RC48-ADC, HER2 expression, Gastric cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

RC48-ADC+Toripalimab+CAPOX

RC48-ADC+Toripalimab+Herceptin

RC48-ADC+Toripalimab+CAPOX(HER2-low)

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Safety(adverse event)

to evaluate safety including adverse event rate and adverse event grade.

Secondary Outcome Measures

Objective remission rate (ORR)

The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).

Progression-free survival (PFS), evaluated by the investigator

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.

Overall survival (OS)

Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

Duration of relief (DOR)

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Full Information

NCT ID

NCT05980481

First Posted

July 1, 2023

Last Updated

August 7, 2023

Sponsor

RemeGen Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05980481

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 30, 2023 (Anticipated)

Primary Completion Date

July 10, 2024 (Anticipated)

Study Completion Date

July 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RemeGen 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

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.

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+.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

RC48-ADC, HER2 expression, Gastric cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RC48-ADC+Toripalimab+CAPOX

Arm Type

Experimental

Arm Description

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).

Arm Title

RC48-ADC+Toripalimab+Herceptin

Arm Type

Experimental

Arm Description

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).

Arm Title

RC48-ADC+Toripalimab+CAPOX(HER2-low)

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

RC48-ADC

Other Intervention Name(s)

Disitamab Vedotin

Intervention Description

2.5 mg/kg IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Herceptin

Other Intervention Name(s)

Trastuzumab

Intervention Description

First load dose is 8.0mg , then 6.0 mg/kg IV every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Other Intervention Name(s)

JS001

Intervention Description

3.0 mg/kg IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin injection

Other Intervention Name(s)

Oxaliplatin

Intervention Description

100mg/m2 Q3W

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Capecitabine Tablets

Intervention Description

1000mg/m2 Q3W

Primary Outcome Measure Information:

Title

Safety(adverse event)

Description

to evaluate safety including adverse event rate and adverse event grade.

Time Frame

Up to approximately 2 years

Secondary Outcome Measure Information:

Title

Objective remission rate (ORR)

Description

The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).

Time Frame

Up to approximately 2 years

Title

Progression-free survival (PFS), evaluated by the investigator

Description

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.

Time Frame

Up to approximately 2 years

Title

Overall survival (OS)

Description

Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

Time Frame

Up to approximately 2 years

Title

Duration of relief (DOR)

Description

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Time Frame

Up to approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian min Fang, PhD

Phone

+86-010-58075561

Email

jianminfang@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Shen, PhD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Na Su, PhD

Organizational Affiliation

RemeGen Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin Shen, PhD

Phone

010-53806898

Email

linshenpku@163.com

Gastric Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial