A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

Launched by REMEGEN CO., LTD. · Mar 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with urothelial carcinoma, a type of cancer that affects the urinary system. The researchers want to see how well a combination of two medications, RC48-ADC and Toripalimab, works compared to traditional chemotherapy for patients who have not yet received any treatment for their advanced cancer. This trial is specifically looking at patients whose cancer cells express a protein called HER2, which is important for determining the right treatment options.

To be eligible for this study, participants should be adults aged 65 and older with locally advanced or metastatic urothelial carcinoma, confirmed by a medical test. They should not have received any previous systemic treatments for this type of cancer, although those who had chemotherapy before surgery and saw their cancer return more than six months later may still qualify. Participants can expect regular check-ups and monitoring throughout the study to ensure their safety and to assess how well the treatment is working. It’s important to know that certain health conditions and previous treatments may exclude someone from participating, so a thorough evaluation will be done before enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Expected survival ≥12 weeks.
• • Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.
• * Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
• • Participants that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; Participants that received adjuvant chemotherapy following cystectomy with recurrence \>6 months from completion of therapy are permitted.
• • At least one measurable lesion based on RECIST version 1.1
• • HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.
• • ECOG performance status score: 0 or 1.
• • Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.
• Exclusion Criteria:
• • Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.
• • History of major surgery within 4 weeks of planned start of trial treatment.
• • Toxicity from a previous treatment has not returned to Grade 0-1.
• • Prior ADCs or PD-1/PD-L1 inhibitor therapy.
• • Active central nervous system (CNS) metastases.
• • Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
• • History of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
• • Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
• • Active autoimmune diseases that require systemic therapy over the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed.
• • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.