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

NCT05297552 | Recruiting Phase 2 DMC

• 1 other identifier: RC48-C017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Muscle Invasive Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 16 Weeks (Time of surgery)

Secondary Outcomes (4)

• Rate of Pathologic Response

  Up to approximately 16 Weeks (Time of surgery)

• 1-year Disease Free Survival Rate

  From approximately 16 Weeks up to approximately 12 Months.

• Objective Response Rate (ORR)

  Up to approximately 12 Weeks.

• Overall Survival (OS)

  Up to approximately 60 Months.

Study Arms (1)

RC48-ADC + JS001

EXPERIMENTAL

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

Drug: RC48-ADC; Drug: JS001

Interventions

RC48-ADC DRUG

Drug: RC48-ADC 2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle

RC48-ADC + JS001

JS001 DRUG

Drug: JS001 3.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle

RC48-ADC + JS001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100078, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Jun Guo, Ph.D

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianmin Fang

CONTACT

+8610-58075763; jianminfang@hotmail.com

Na Su

CONTACT

+8610-58075763; na.su@remegen.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: May 26, 2022
• Primary Completion: June 1, 2024
• Study Completion: February 28, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (3)