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Tests treatment safety and results for Locally Advanced or Metastatic Breast Cancer
Official title A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
ClinicalTrials.gov ID: NCT06439771
What this study is testing
What is YL202 should be intravenously infused?
YL202 should be intravenously infused is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced or metastatic breast cancer.
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 study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression
- 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 75, women only
You may be able to join if
- Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
- Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system [Version 8]) who are not candidates for curative...
- Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
- Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
- Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
You likely can't join if
- Have prior treatment with an agent targeting HER3.
- Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
- Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an treatment...
- Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
- Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the...
- Have prior allogeneic bone marrow transplant or prior solid organ transplant.
See the full eligibility criteria
- Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
- Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system [Version 8]) who are not candidates for curative surgery or radiotherapy.
- Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
- Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
- Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
- Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Have Adequate organ and bone marrow function within 7 days prior to the first dose.
- Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
- Have a expected survival ≥ 3 months.
- Have ability and willingness to comply with protocol-specified visits and procedures.
- Have prior treatment with an agent targeting HER3.
- Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
- Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an treatment study.
- Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
- Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.
- Have prior allogeneic bone marrow transplant or prior solid organ transplant.
- Have received treatment with systemic steroids.
- Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.
- Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
- Brain metastases with the exceptions.
- Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
- Have clinically significant concomitant pulmonary diseases.
- Have a diagnosis of Gilbert's syndrome.
- Have pleural effusion, abdominal effusion.
- Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.
- Have serious infection.
- Patients with human immunodeficiency virus (HIV) infection.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Have any other primary malignancy within 5 years prior to the first dose of study drug.
- Have unresolved toxicities from prior anticancer therapy.
- Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
- Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai 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 female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai 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.