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
Qualifiers
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
Treatments tested in this trial
- SKB445 for injection
Treatment groups
126 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov