SKB565 for Injection in Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SKB565
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov