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New treatment option for Locally Advanced or Metastatic Urothelial Carcinoma
Official title A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
ClinicalTrials.gov ID: NCT07393542
What this study is testing
What is SHR-A2102 and Adebrelimab?
SHR-A2102 and Adebrelimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for locally advanced or metastatic urothelial carcinoma.
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
- The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Be able to sign the informed consent form in writing.
- Female or male, 18 to 80 years of age (both inclusive).
- ECOG performance status of 0 or 1.
- Expected survival of≥ 3 months.
- Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic...
You likely can't join if
- Planned to receive any other anti-tumor therapy during the study.
- Received other investigational products or treatments not yet marketed within 4 weeks.
- Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks...
- Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing...
- Prior treatment with immune checkpoint inhibitors.
- Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial.
See the full eligibility criteria
- Be able to sign the informed consent form in writing.
- Female or male, 18 to 80 years of age (both inclusive).
- ECOG performance status of 0 or 1.
- Expected survival of≥ 3 months.
- Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease.
- No prior systemic therapy for locally advanced or metastatic disease.
- Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
- According to RECIST v1.1, there must be at least one measurable lesion;
- Tolerant to cisplatin or carboplatin.
- Adequate organ functions.
- Agree to use medically approved contraceptive measures.
- Planned to receive any other anti-tumor therapy during the study.
- Received other investigational products or treatments not yet marketed within 4 weeks.
- Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks; palliative radiotherapy or local therapy within 2 weeks.
- Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing irinotecan or its derivatives and acting as a topoisomerase I inhibitor.
- Prior treatment with immune checkpoint inhibitors.
- Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial.
- Active autoimmune disease requiring systemic treatment within 2 years.
- Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.0.
- Uncontrolled central nervous system metastases or carcinomatous meningitis.
- people with clinical symptoms or serous cavity effusion requiring puncture drainage.
- Other malignancies within 5 years.
- History of clinically significant pulmonary disease or any such disease suggested by chest imaging at screening.
- Serious infections requiring intravenous antibiotics, antivirals, or antifungals for control.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- History of immunodeficiency, or history of organ transplant.
- Have experienced arteriovenous thrombosis or cardiovascular and cerebrovascular accidents within 6 months.
- people with clinically significant hemorrhage within 3 months.
- Glycosylated hemoglobin (HbA1c) ≥ 8%.
- Have serious cardiovascular and cerebrovascular diseases.
- Allergic reaction to any component of the study treatment.
- people with active pulmonary tuberculosis.
- Have severe dry eye, active keratitis, or corneal ulcer, or other conditions.
- Female people who are pregnant or planning to become pregnant during the study.
- Other conditions unsuitable into the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.