SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin ConjuStar Biologics Co., Ltd.
About this trial
This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
SC-101
DrugReceive 7.5 mg/m² of SC-101 intravenously once weekly (QW).
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: TNBC, HR+HER2- BC, and other tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
cORR
Investigator-assessed confirmed objective response rate
Time frame
Baseline (Day -28 to Day -1); tumor response will be evaluated every 8 weeks (±7 days) from the first dose of study treatment to the data cut-off date, up to 24 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: