Actively Recruiting
SKB105 for Injection in Advanced Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
256
Participants Needed
2
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2 clinical study to evaluate the safety and efficacy of SKB105 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
CONDITIONS
Official Title
SKB105 for Injection in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily joined this study and signed an informed consent form.
- Age between 18 and 75 years at the time of signing the informed consent.
- Histologically or cytologically confirmed advanced solid tumors with failed standard therapy, no available standard therapy, or intolerance to standard therapy.
- Willingness to provide tumor tissue samples for biomarker testing during screening.
- At least one measurable lesion present based on RECIST Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival period of 12 weeks or more.
- Adequate bone marrow, liver, kidney, and coagulation functions.
- Agreement by male and female participants to use highly effective contraceptive methods during the study period.
You will not qualify if you...
- Presence of meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active central nervous system (CNS) metastasis.
- History of other malignant tumors within 3 years before first administration.
- Serious heart or vascular diseases or high-risk factors.
- Uncontrollable systemic disease judged by researchers.
- Pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage more than once per week.
- History of interstitial lung disease or non-infectious pneumonia.
- Other lung diseases that could interfere with drug-related pulmonary toxicity.
- Severe dry eye syndrome, severe meibomian gland disease, blepharitis, or corneal diseases hindering or delaying corneal healing.
- Unresolved toxicity from previous anti-tumor treatments not recovered to CTCAE Version 6.0 grade 0 or 1.
- Risk of developing esophagotracheal or esophageal pleural fistula, or tumor invasion/compression of important organs and blood vessels with symptoms.
- Clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, or abdominal abscess within 3 months prior to first administration.
- Serious infection within 4 weeks before first administration.
- Active hepatitis B or C, simultaneous infection with HBV and HCV.
- Positive HIV test or history of AIDS; known active syphilis infection.
- Known active pulmonary tuberculosis.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Allergy or severe hypersensitivity to SKB105 components or other monoclonal antibodies.
- Prior therapy targeting Integrin β6 or any topoisomerase I inhibitors.
- Chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks prior to first administration.
- Lung lesions treated with radiation over 30 Gray within 6 months prior to first administration.
- Major surgery or serious injury within 28 days prior to first administration.
- Treatment with other investigational drugs within 28 days prior to first administration.
- Received anti-tumor vaccines or any active vaccines within 28 days prior to first administration.
- Systemic corticosteroid therapy or immunosuppressive drugs over 10 mg/day prednisone within 2 weeks prior to first dose.
- Use of strong cytochrome P450 or BCRP inhibitors or inducers within 14 days before first administration or 5 half-lives.
- Pregnant or lactating women.
- History of mental illness or substance abuse impacting study cooperation.
- Local or systemic diseases caused by non-malignant tumors or secondary to tumors affecting compliance.
- Any condition judged by researchers as interfering with drug evaluation, participant safety, or study results interpretation.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Shangahi Chest Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
Research Team
Y
Yina Diao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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