SKB565 for Injection in Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SKB565
DrugIV infusion on Day 1 and Day 15 of each cycle, every 4 weeks (Q4W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: SKB565 monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 28 days and is at least possibly related to the study drug.
Time frame
At the end of Cycle 1 of the dose-escalation phase (each cycle is 28 days)2
Objective response rate (ORR)
To evaluate the ORR of SKB565 as assessed by the investigator based on RECIST v1.1.
Time frame
Up to approximately 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov