SKB118 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 multicenter, open-label, Phase I/II clinical study. The study is divided into two parts, the SKB118 monotherapy study and the SKB118 in combination with SKB264 study.
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.
Participants should provide tumor tissue samples for biomarker testing as much as possible.
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
SKB118 Injection
DrugSKB118 Injection monotherapy, iv drip, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
SKB118+SKB264
DrugAdministered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.
Treatment groups
530 Participants
are divided into 2 treatment groupsGroup A: SKB118 Injection monotherapyExperimental treatment 1 intervention
Group B: SKB118 in combination with SKB264Experimental 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 DLT observation period (within 21 days after the first dose for q3w dosing frequency; within 28 days after the first dose for q2w dosing frequency) and is at least possibly related to the study drug.
Time frame
From date of initial dose until up to 21 days after the first dose for q3w dosing frequency; or up to 28 days after the first dose for q2w dosing frequency2
Objective response rate (ORR)
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Time frame
Up to approximately 3 yearsSecondary outcomes
1
Progression Free Survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame
Up to approximately 3 years2
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame
Up to approximately 3 years3
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Time frame
Up to approximately 3 years4
Maximum observed plasma concentration (Cmax) of SKB118
Pharmacokinetic (PK) parameters of SKB118
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov