Combining RC48-ADC and AK104 for treating muscle-invasive bladder cancer

An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With AK104 in Perioperative Treatment of Muscle-Invasive Bladder Cancer

This study is testing a new combination of two treatments for people with muscle-invasive bladder cancer to see if it helps them before and after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06074484 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of intravenous RC48-ADC combined with AK104 in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy. A total of 36 patients will receive 4 cycles of neoadjuvant therapy followed by 14 cycles of adjuvant therapy. Eligible participants must have HER2 expression in their tumor tissues and have not previously undergone any antitumor systemic therapy. The study aims to assess the treatment's impact on patient outcomes and tumor response.

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 antitumor therapy.

Not a fit: Patients with metastatic bladder cancer or those who have previously received antitumor systemic treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with muscle-invasive bladder cancer by enhancing tumor response and survival rates.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies in treating various cancers, suggesting potential for success in this approach.

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. 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.
* 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

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Nianzeng Xing, Doctor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: xin wang, Doctor

Conditions Muscle Invasive Bladder Carcinoma; RC48-ADC; AK104