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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SKB103 monotherapy
DrugSKB103 for injection, administered as monotherapy via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks, Q3W). Treatment continues until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death, whichever occurs first.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Participant GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as any adverse event (AE) that meets protocol-defined DLT criteria, occurring in the first 21 days, and considered at least possibly drug-related.
Time frame
Within the first 21 days following the initial dose.2
Objective response rate(ORR)
ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.
Time frame
Up to approximately 3 yearsSecondary outcomes
1
Progression-free survival (PFS)
PFS is defined as the time from the first dose to progressive disease (PD) or death, whichever occurs first. PD will be assessed per RECIST 1.1.
Time frame
Up to approximately 3 years2
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in participants to PD or death due to any reason.
Time frame
Up to approximately 3 years3
Disease control rate (DCR)
DCR is defined as the proportion of participants with CR, PR or stable disease (SD) as the best overall response assessed per RECIST 1.1.
Time frame
Up to approximately 3 years4
Overall Survival (OS)
Time from start of treatment to death due toany reason.
Time frame
Up to approximately 3 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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