A Study of SKB518 in Patients With Advanced Solid Tumors (NCT06428331) | Clinical Trial Compass
RecruitingPhase 1
A Study of SKB518 in Patients With Advanced Solid Tumors
China150 participantsStarted 2024-07-04
Plain-language summary
This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be at least 18 years of age at the time of signing the informed consent;
✓. Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments.
✓. Subjects able to provide tumor blocks or 8\~10 slides \[fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)\] before the first dose of study intervention for biomarkers testing.
✓. At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
✓. Life expectancy of at least 3 months as assessed by the investigators.
✓. Subjects with adequate organ and bone marrow function confirmed by laboratory results within 7 days prior to the first dose.
✓. Has recovered from all toxicities from previous therapy with the exception of stable, chronic (\>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor.
Exclusion criteria
✕. Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
What they're measuring
1
Number of subjects achieving Dose-limiting toxicity (DLT)
Timeframe: From data of initial dose until up to 21 days for treatment
2
Maximum Tolerated Dose (MTD)
Timeframe: From data of initial dose until up to 21 days for treatment