Study of SKB103 in HER2-negative Breast Cancer
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.
Eligibility criteria
Qualifiers
Willingness to participate in the study, sign the informed consent form(ICF), and comply with the protocol-specified visits and relevant procedures.
Aged ≥ 18 and ≤ 75 years at the time of signing ICF.
Histologically and/or cytologically confirmed HER2-negative Breast cancer who have failed standard therapy.
Participants should provide tumor tissue samples for biomarker testing as much as possible.
Disqualifiers
Participants with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active central nervous system (CNS) metastases.
Participants with other malignant tumors within 3 years prior to the first administration.
Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
Presence of any uncontrolled systemic disease, as judged by the investigator.
Trial design
Treatments tested in this trial
- SKB103 monotherapy
Treatment groups
140 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov