SKB445 for Injection in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SKB445 for injection.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB445 for Injection in Patients With Advanced Solid Tumors
Overview
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.
Detailed description
This is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor activity of SKB445 monotherapy in patients with advanced solid tumors.
Interventions
- Drug SKB445 for injection
SKB445 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Primary outcome measures
- Number of subjects achieving Dose-limiting toxicity (DLT) [Time frame: From date of initial dose until up to 21 days for treatment]
Secondary outcome measures (4)
- Objective Response Rate (ORR) [Time frame: Up to 3 years]
- Progression Free Survival (PFS) [Time frame: Up to 3 years]
- Duration of Response (DOR) [Time frame: Up to 3 years]
- Overall Survival (OS) [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- 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.
- Subjects with adequate organ and bone marrow function confirmed by laboratory results
- Subjects of childbearing potential (male or female) must use effective medical contraception during the study
- Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
Exclusion criteria
- 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.
- Presence of active central nervous system (CNS) metastases.
- Has uncontrolled or severe cardiovascular disease.
- Has uncontrolled systemic diseases.
- Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
- Subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study.
- Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital of Shandong First Medical University — Jinan
Identifiers
NCT: NCT06826040 · SKB445-I-01