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New treatment option for Urothelial Carcinoma
Official title Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)
ClinicalTrials.gov ID: NCT07241793
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, being studied as a potential treatment for 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
- This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).
- Phase 2: a mid-size study of how well it works
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
- Patients included in this study must meet all of the following criteria:
- Age ≥ 18 years;
- Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma...
- Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed/progressed within 12 months after the last treatment, or who...
- At least one measurable target lesion according to RECIST 1.1 criteria;
You likely can't join if
- Locally advanced patients who are candidates for curative local treatment;
- Clinical history of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological/psychiatric diseases;
- Known or untreated spinal cord compression or active central nervous system metastases, except for those who have been treated and stable for at...
- Known severe allergic reactions to the study drug's active ingredients and/or excipients, or allergy to humanized monoclonal antibody products (e.g...
- Received antitumor monoclonal antibody treatment within 4 weeks before the study start, or received other antitumor therapy without recovery from...
- Participated in any investigational drug treatment within 4 weeks before the study started;
See the full eligibility criteria
- Patients included in this study must meet all of the following criteria:
- Age ≥ 18 years;
- Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma (la/mUC), including bladder, ureter, renal pelvis, and urethra. HER2...
- Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed/progressed within 12 months after the last treatment, or who could not tolerate treatment due to adverse events (AEs). Cohort 2...
- At least one measurable target lesion according to RECIST 1.1 criteria;
- ECOG performance status ≤ 2;
- Adequate bone marrow, renal (calculated creatinine clearance \> 30 mL/min using the CG formula), hepatic, and coagulation function;
- Expected survival ≥ 3 months;
- The patient understands the study procedures and has provided written informed consent to participate in the study;
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test is...
- Both male and female participants must agree to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) and continue contraception until at least 180 days after the end of study...
- Locally advanced patients who are candidates for curative local treatment;
- Clinical history of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological/psychiatric diseases;
- Known or untreated spinal cord compression or active central nervous system metastases, except for those who have been treated and stable for at least 1 month and have discontinued corticosteroids for \> 2 weeks;
- Known severe allergic reactions to the study drug's active ingredients and/or excipients, or allergy to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab);
- Received antitumor monoclonal antibody treatment within 4 weeks before the study start, or received other antitumor therapy without recovery from adverse events;
- Participated in any investigational drug treatment within 4 weeks before the study started;
- Known or suspected interstitial lung disease, or moderate to severe pulmonary diseases that might interfere with the evaluation of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary...
- Known hereditary or acquired bleeding disorders (e.g., hemophilia, coagulopathy);
- Received spinal cord radiation or has not recovered from radiation-related adverse events within 4 weeks before study start;
- Diagnosed with immunodeficiency or received systemic corticosteroid treatment or any other immunosuppressive therapy within 7 days before the first study drug administration. Physiological doses of corticosteroids (≤10...
- Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., requiring disease-modifying drugs, corticosteroids, or immunosuppressants). Replacement therapies (e.g., thyroid hormones, insulin...
- History of organ or hematopoietic stem cell transplantation;
- Known HIV infection (HIV 1/2 positive);
- Untreated active hepatitis B (HBV). Note: Hepatitis B carriers with an HBV viral load \< 1000 copies/mL (200 IU/mL) before the first dose are eligible, but should receive antiviral therapy during chemotherapy to prevent...
- Active hepatitis C (HCV) infection (HCV antibody positive and HCV RNA level above detection threshold;
- Received live vaccines within 30 days before the first dose of the study drug. Note: Inactivated flu vaccines are allowed within 30 days before the first dose, but live attenuated flu vaccines are not permitted.
- History of other malignancies within the past 3 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or low-risk prostate cancer (T2N0M0, Gleason score \<7, or undetectable PSA);
- Any condition or disease history that may interfere with the study results or hinder the participant's full participation, including abnormal laboratory values, or situations deemed inappropriate by the investigator;
- Breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Nanchang, Jiangxi, China
- Kunming, Yunnan, 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 Guangzhou, Guangdong, China; Wuhan, Hubei, China; Nanchang, Jiangxi, China; Kunming, Yunnan, 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.