Actively Recruiting
A Study of SKB315 in Patients With Advanced Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
246
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 SKB315 for injection in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of SKB315 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 80 years (inclusive) at the time of consent
- Histologically or cytologically confirmed advanced solid tumors with Claudin18.2 expression
- Patients who have failed standard care, have no standard care options, or are unqualified for standard care
- Presence of at least one measurable tumor lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated survival of at least 3 months
- Adequate organ and bone marrow function without recent blood component or cytokine treatments
- Recovery to Grade 1 or less from previous treatment toxicities before study treatment
- Use of effective contraception during the study and for 6 months after treatment if of childbearing potential
- Voluntary participation and ability to comply with study visits and procedures
- For Phase 1b combination: unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive expression
- ECOG score 0-1 and expected survival of at least 3 months
- At least one measurable lesion meeting RECIST 1.1 criteria
- Adequate bone marrow and organ function
You will not qualify if you...
- Received other clinical study drugs, major surgery, or anti-tumor therapies within 4 weeks before the first dose
- Previous therapy targeting Claudin18.2
- Planning to receive other anti-tumor therapies during the study
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives before the first dose
- Other malignancies within 5 years before consent
- Pregnant or breastfeeding women
- Known allergies to SKB315 or other monoclonal antibodies
- History of alcohol abuse or drug abuse
- Active hepatitis B or C infection
- HIV positive status
- Active severe digestive diseases
- Major cardiovascular disease history
- Serious lung disease or impaired respiratory function
- History of serious dementia, altered mental status, or psychiatric disorders
- Brain or central nervous system metastases
- Clinically significant systemic diseases affecting safety
- Poor compliance potential or other factors deemed unsuitable by investigator
- For Phase 1b combination: HER2 positive tumor expression
- History of brain metastases
- Additional malignancies within 5 years prior to treatment
- Active or history of autoimmune disease
- Recent systemic corticosteroids or immunosuppressants use
- History of immunodeficiency including positive HIV
- Active hepatitis B or C
- Other factors that could affect study results or cause early study termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Y
Yi Ba, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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