A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
ConditionSolid Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Eligibility criteria
Qualifiers
Subjects aged 18-75 years at the time of signing the informed consent form
Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .
Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
Disqualifiers
Subjects with known active or untreated central nervous system (CNS) metastases.
Subjects with other malignant tumors within 3 years prior to the first dose.
Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
Subjects with known active pulmonary tuberculosis.
Trial design
Treatments tested in this trial
- SKB571
Treatment groups
138 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov