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New treatment option for Urothelial Carcinoma
Official title Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy
ClinicalTrials.gov ID: NCT07506057
What this study is testing
What is Trastuzumab+Serplulimab?
Trastuzumab+Serplulimab is an investigational medicine, given as an infusion into a vein, 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
- his single-center phase II clinical study enrolls patients with unresectable locally advanced or metastatic HER2-overexpressing biliary tract cancer or urothelial carcinoma who have failed standard treatment. Participants receive trastuzumab in combination with serplulimab and chemotherapy.
- 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 to 85
You may be able to join if
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed recurrent and/or metastatic advanced biliary tract cancer or urothelial carcinoma.
- Disease progression after at least one prior line of systemic antitumor therapy. For patients who received systemic antitumor therapy during adjuvant...
- HER2 overexpression confirmed by immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH)+.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
You likely can't join if
- Known HER2-negative or HER2-low expression.
- Active autoimmune disease or history of autoimmune disease with potential for relapse. Patients with the following conditions are not excluded and...
- Presence of other malignancies within the past 2 years or currently, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (at least once per month) within 14 days prior to...
- Weight loss ≥ 20% within 2 months prior to enrollment.
- Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA \> 500 IU/mL, or patients positive for HCV RNA. Patients with inactive HBsAg...
See the full eligibility criteria
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed recurrent and/or metastatic advanced biliary tract cancer or urothelial carcinoma.
- Disease progression after at least one prior line of systemic antitumor therapy. For patients who received systemic antitumor therapy during adjuvant therapy or concurrent chemoradiotherapy, progression occurring within...
- HER2 overexpression confirmed by immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH)+.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- No prior anti-HER2 therapy.
- At least one measurable lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ reserve function:
- Urine protein ≤ 1+ on urinalysis or 24-hour urine protein \ 2.7 g/dL.
- Life expectancy ≥ 3 months as judged by the investigator.
- Ability to provide written informed consent and understand and agree to comply with study requirements and assessment schedule.
- Female patients of childbearing potential must agree to use highly effective contraception during the treatment period and for 12 weeks after the last dose; male patients must agree to use highly effective contraception...
- Known HER2-negative or HER2-low expression.
- Active autoimmune disease or history of autoimmune disease with potential for relapse. Patients with the following conditions are not excluded and may proceed to further screening
- Presence of other malignancies within the past 2 years or currently, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta, Tis, and T1).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (at least once per month) within 14 days prior to enrollment.
- Weight loss ≥ 20% within 2 months prior to enrollment.
- Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA \> 500 IU/mL, or patients positive for HCV RNA. Patients with inactive HBsAg carriers, those with hepatitis B who have been treated and are stable (HBV...
- Known allergy to any study drug or excipient.
- Palliative radiotherapy within 14 days prior to enrollment.
- Prior anti-HER2 therapy.
- Major surgery within 28 days prior to enrollment, except for minimally invasive procedures such as peripherally inserted central catheter (PICC) placement. Major surgery within 28 days prior to enrollment, except for...
- Any underlying medical condition, or alcohol/drug abuse or dependence, that in the investigator's opinion would interfere with study drug administration or affect the interpretation of drug toxicity or adverse events.
- Concurrent participation in another therapeutic clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, 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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, 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.