SKB565 for Injection in Advanced Solid Tumors (NCT07545265) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
SKB565 for Injection in Advanced Solid Tumors
China180 participantsStarted 2026-06
Plain-language summary
This is a phase I/II clinical study to evaluate the safety and efficacy of SKB565 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.
✓. 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.
✓. Male and female participants must agree to use highly effective contraceptive methods during the study period.
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.
✕
What they're measuring
1
Number of subjects achieving Dose-limiting toxicity (DLT)
Timeframe: Day 1 to Day 28 in Cycle 1 in the dose escalation part
. According to researchers' judgment, it is an uncontrollable systemic disease.
✕. There are pleural, pericardial, or ascitic effusions that are poorly controlled, symptomatic, or requiring repeated drainage.
✕. History of interstitial lung disease or non infectious pneumonia.
✕. There are other lung diseases that may interfere with drug-related pulmonary toxicity.
✕. Severe dry eye syndrome, severe conjunctivitis, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.