A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

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 ofantitumor systematic treatment or radiotherapy.
• Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined byimaging. 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 ofantitumor systematic treatment or radiotherapy.
• Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined byimaging.
• 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 daysprior to the study treatment.
• Male and female participants are eligible to participate if they agree to thecontraception use as per study protocol.
• Willing to adhere to the study visit schedule and the prohibitions and restrictionsspecified 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 daysprior to the study treatment.
• Male and female participants are eligible to participate if they agree to thecontraception use as per study protocol.
• Willing to adhere to the study visit schedule and the prohibitions and restrictionsspecified 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, orHIVAb 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 orimmunosuppressants) for the autoimmune disease within 2 years prior to the studytreatment.
• History of other malignancy within the previous 5 years, except for appropriatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers witha similar curative outcome as those mentioned above.
• Has a history or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the trial, interfere with the subject'sparticipation for the full duration of the trial, or is not in the best interest ofthe 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 requirementsof the protocol.