SKB445 for Injection in Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At the time of signing the ICF: age between 18 -75 years, male or female.
subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
Expected survival ≥ 3 months.
Disqualifiers
Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
Has had major surgery within 4 weeks prior to the first dose.
Has known history of allergy to any component of SKB445 or SKB445.
Has a known previous or concurrent other malignancies within 3 years prior to first dose.
Trial design
Design model
Single group
Treatments tested in this trial
SKB445 for injection
DrugSKB445 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: Dose Escalation PhaseExperimental 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 cycle 1 and is at least possibly related to study drug.
Time frame
From date of initial dose until up to 21 days for treatmentSecondary outcomes
1
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 3 years2
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 3 years3
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 3 years4
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov