Treatment for advanced or metastatic urothelial carcinoma using RC48-ADC and AK104

An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With AK104 in HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

This study is testing a new combination treatment for people with advanced bladder cancer to see if it works better than traditional chemotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanxi Province Cancer Hospital (other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 2 sites (北京, Beijing and 1 other locations)
• Trial ID: NCT06178601 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of a combination therapy involving RC48-ADC and AK104 for patients with HER2-expressing locally advanced or metastatic urothelial carcinoma. Participants must have confirmed diagnosis and meet specific eligibility criteria, including performance status and organ function. The study aims to provide a new treatment option for patients who cannot tolerate traditional chemotherapy. The approach focuses on targeting HER2 expression to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with HER2-expressing locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Not a fit: Patients who have received prior systemic therapy or those who are not HER2-expressing may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced urothelial carcinoma who have limited treatment choices.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches targeting HER2 in urothelial carcinoma have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 6 month.
* Histologically and/or cytologically confirmed locally advanced or metastatic urothelial carcinoma (including urothelial carcinoma originating in the renal pelvis, ureter, bladder, or urethra).
* Pior not received systemic therapy, and can not tolerant cisplatin or refuse chemotherapy.
* 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.
* Have at least one evaluable lesion (RECIST 1.1 criteria)
* 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.
* Previously received allogeneic stem cell or parenchymal organ transplantation;
* Previously or currently suffering from congenital or acquired immunodeficiency diseases;
* known or suspected to have a history of allergies to similar drugs such as RC48-ADC and anti-PD-1, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug.
* 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 or IV heart failure.
* Suffering from active infection requiring systemic treatment.
* Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
* Required systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to enter the trial.
* 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 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

北京, Beijing and 1 other locations

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — 北京, Beijing, China (RECRUITING)
• Shanxi Province Cancer Hospital — Taiyuan, Shanxi, China (RECRUITING)

Study contacts

• Study coordinator: Wang Xin Doctor

Conditions: Urothelial Carcinoma