Locally Advanced or Metastatic Breast Cancer
Conditions
Brief summary
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.
Interventions
DRUGYL202
IV infusion on day 1 of each 21 day cycle
DRUGEribulin
1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUGCapecitabine
1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle
DRUGGemcitabine
1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUGVinorelbine
25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUGSacituzumab govitecan
10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle
Sponsors
MediLink Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form. 2. Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy. 3. Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage. 4. Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1. 5. Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 7. Have Adequate organ and bone marrow function within 7 days prior to the first dose. 8. 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. 9. Have a expected survival ≥ 3 months. 10. Have ability and willingness to comply with protocol-specified visits and procedures.
Exclusion criteria
1. Have prior treatment with an agent targeting HER3. 2. Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor. 3. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug. 4. 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. 5. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression. 6. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease. 7. Have clinically significant concomitant pulmonary diseases. 8. Have uncontrolled pleural effusion, abdominal effusion. 9. Have serious infection within 4 weeks prior to the first dose. 10. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. | up to 18 months | PFS is defined as time from randomization until disease progression or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to 36 months | OS is defined as time from randomization until the date of death due to any cause. |
| Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 | up to 18 months | PFS is defined as time from randomization until disease progression or death due to any cause. |
| Objective Response Rate (ORR) | up to 18 months | Objective response rate is defined as the proportion of participants who have a CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1. |
| Duration of Response (DoR) | up to 18 months | Duration of response is defined as the time from the date of first documented confirmed response until disease progression, as determined by BICR/Investigator assessment or death due to any cause. |
| Disease Control Rate (DCR) | up to 18 months | DCR is defined as the percentage of participants who have a CR, PR or SD, per RECIST 1.1, as determined by BICR/Investigator assessment, per RECIST 1.1. |
| Adverse Events (AEs) | up to 36 months | Incidence and severity of AEs and clinically significant abnormal laboratory findings. |
Countries
China
Contacts
CONTACTMedilink Study Team
Outcome results
None listed