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A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

Primary Purpose

Muscle Invasive Bladder Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC48-ADC
JS001
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Invasive Bladder Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.
  • Male or female, Age ≥ 18 years.
  • Predicted survival ≥ 12 weeks.
  • Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC) .Naive of antitumor systematic treatment or radiotherapy.
  • Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by imaging.
  • Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
  • HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
  • Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Has received other antitumor therapy before planned start of trial treatment.
  • History of major surgery within 4 weeks of planned start of trial treatment.
  • Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
  • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  • NYHA Class III heart failure.
  • Suffering from active infection requiring systemic treatment.
  • Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
  • Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Pregnancy or lactation.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RC48-ADC + JS001

Arm Description

Participants received 6 preoperative cycles of RC48-ADC PLUS JS001, followed by surgery, followed by up to 20 cycles of postoperative JS001.

Outcomes

Primary Outcome Measures

Pathologic Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue from RC and PLND.

Secondary Outcome Measures

Rate of Pathologic Response
No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen.
1-year Disease Free Survival Rate
The percentage of participants disease free on 1 year after surgery.
Objective Response Rate (ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death due to any cause.

Full Information

First Posted
March 17, 2022
Last Updated
February 14, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05297552
Brief Title
A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
Official Title
An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With JS001 in Perioperative Treatment of Muscle-Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
February 28, 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
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in perioperative treatment of muscle-invasive bladder cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Invasive Bladder Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
RC48-ADC + JS001
Arm Type
Experimental
Arm Description
Participants received 6 preoperative cycles of RC48-ADC PLUS JS001, followed by surgery, followed by up to 20 cycles of postoperative JS001.
Intervention Type
Drug
Intervention Name(s)
RC48-ADC
Intervention Description
Drug: RC48-ADC 2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Intervention Type
Drug
Intervention Name(s)
JS001
Intervention Description
Drug: JS001 3.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Primary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue from RC and PLND.
Time Frame
Up to approximately 16 Weeks (Time of surgery)
Secondary Outcome Measure Information:
Title
Rate of Pathologic Response
Description
No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen.
Time Frame
Up to approximately 16 Weeks (Time of surgery)
Title
1-year Disease Free Survival Rate
Description
The percentage of participants disease free on 1 year after surgery.
Time Frame
From approximately 16 Weeks up to approximately 12 Months.
Title
Objective Response Rate (ORR)
Description
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time Frame
Up to approximately 12 Weeks.
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from enrollment to death due to any cause.
Time Frame
Up to approximately 60 Months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary agreement to provide written informed consent. Male or female, Age ≥ 18 years. Predicted survival ≥ 12 weeks. Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC) .Naive of antitumor systematic treatment or radiotherapy. Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by imaging. Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. Exclusion Criteria: Has received other antitumor therapy before planned start of trial treatment. History of major surgery within 4 weeks of planned start of trial treatment. Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive. Has received a live virus vaccine within 4 weeks of planned start of trial treatment. NYHA Class III heart failure. Suffering from active infection requiring systemic treatment. Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD; Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment. History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Pregnancy or lactation. 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
Jianmin Fang
Phone
+8610-58075763
Email
jianminfang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Na Su
Phone
+8610-58075763
Email
na.su@remegen.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Ph.D
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo
First Name & Middle Initial & Last Name & Degree
Jun Guo, Ph.D
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Yang
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhisong He

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

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