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New treatment option for Urothelial Carcinoma
Official title A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
ClinicalTrials.gov ID: NCT05302284
What this study is testing
What is RC48-ADC?
RC48-ADC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urothelial carcinoma.
Also referred to as Disitamab Vedotin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Expected survival ≥12 weeks.
- Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder...
- Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions...
- 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+.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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)...
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.