A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

Launched by SHANXI PROVINCE CANCER HOSPITAL · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced or metastatic urothelial carcinoma, which is a type of bladder cancer. The trial is testing a combination of two drugs: RC48-ADC and AK104, to see how well they work together in patients who have a specific protein called HER2 that can promote cancer growth. Researchers are looking for participants who are at least 18 years old, have not received prior systemic therapy, and have a predicted survival of at least six months.

Eligible participants will need to agree to take part in the study and have an appropriate health status, as determined by their doctor. They should be able to attend regular study visits and meet certain health criteria, such as having good organ function and a specific performance status. During the study, participants will receive the new treatment and be monitored for its effectiveness and any side effects. It’s important to know that those with certain health issues or previous treatments may not qualify, so it's essential to discuss eligibility with a healthcare provider.

Gender

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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.