SKB103 for Injection in Advanced Solid Tumors (NCT07459998) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
SKB103 for Injection in Advanced Solid Tumors
China277 participantsStarted 2026-04-30
Plain-language summary
This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants voluntarily joined this study and signed an informed consent form.
✓. The age at the time of signing the informed consent form must be between 18 and 75 years.
✓. Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.
✓. Participants should provide tumor tissue samples for biomarker testing as much as possible.
✓. Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.
✓. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.
✓. Expected survival period ≥ 12 weeks.
✓. Participants have sufficient bone marrow, liver, kidney, and coagulation functions.
Exclusion criteria
✕. Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, and active central nervous system (CNS) metastasis.
✕. Patients with other malignant tumors within 3 years before the first administration.
✕. There are serious heart or vascular diseases or high-risk factors present.
✕. According to researchers' judgment, it is an uncontrollable systemic disease.
What they're measuring
1
Number of subjects achieving Dose-limiting toxicity (DLT)
Timeframe: From date of initial dose until up to 21 days for treatment