Combining RC48-ADC and JS001 for treating muscle-invasive bladder cancer before surgery

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

This study is testing a new combination treatment of RC48-ADC and JS001 to see if it helps adults with muscle-invasive bladder cancer before they have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RemeGen Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT05297552 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of an intravenous treatment combining RC48-ADC and JS001 for patients with muscle-invasive bladder cancer (MIBC) in the perioperative setting. Participants will be adults with a confirmed diagnosis of MIBC who have not received prior systemic treatment or radiotherapy. The study aims to determine how well this combination therapy works before surgical intervention, specifically radical cystectomy and pelvic lymph node dissection. Patients will be monitored for their response to treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed muscle-invasive bladder cancer who have not received prior treatment.

Not a fit: Patients with metastatic bladder cancer or those who have previously undergone systemic treatment or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with muscle-invasive bladder cancer undergoing surgery.

How similar studies have performed: While similar approaches have been explored, this specific combination of RC48-ADC and JS001 in the perioperative treatment of MIBC is novel.

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.

Where this trial is running

Beijing, Beijing and 2 other locations

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jun Guo, Ph.D — Peking University Cancer Hospital & Institute
• Study coordinator: Jianmin Fang

Conditions Muscle Invasive Bladder Carcinoma