Actively Recruiting
JSKN022 in Subjects With Advanced Malignant Solid Tumors
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2025-12-23
225
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic/ pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.
CONDITIONS
Official Title
JSKN022 in Subjects With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign the informed consent form.
- Age 18 years or older, any gender.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Expected survival of 3 months or more.
- Histologically or cytologically confirmed malignant solid tumors that have failed previous standard treatment, are intolerant to standard treatment, or have no access to standard treatment.
- At least one measurable lesion at baseline according to RECIST 1.1 criteria.
- Adequate organ function.
- Agree to provide recently archived or fresh tumor tissue samples.
- Use effective contraception if of childbearing potential.
- Negative pregnancy test within 7 days before the first dose for females of childbearing potential.
- Able and willing to comply with visits, treatment plans, laboratory tests, and other study procedures.
- Adequate washout period from previous therapy before the first dose.
You will not qualify if you...
- Other malignant tumors within 5 years before the first dose, except for those clinically cured or with very low recurrence risk.
- History of brainstem, meningeal, spinal cord metastasis or compression, carcinomatous meningitis, or active brain metastasis.
- Tumor invasion or compression of important organs or risk of certain fistulas unless deemed safe by investigators.
- Severe respiratory impairment caused by lung disease complications.
- Risk factors for interstitial lung disease or non-infectious pneumonia.
- Cardiovascular or cerebrovascular diseases or risk factors.
- Gastrointestinal abnormalities with obvious clinical symptoms.
- Active autoimmune diseases requiring systemic treatment within past 2 years.
- Significant serous effusion.
- Uncontrolled infection.
- Need for regular glucocorticoid or immunosuppressive therapy.
- Received live vaccines within 28 days before first dose or plans to receive during study.
- Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.
- Previous grade 3 or higher immune-related adverse events during immunotherapy.
- Toxicity from previous anti-tumor treatments not fully recovered.
- Known allergy to study drug components or severe allergic reactions to antibody drugs.
- Pregnant, lactating, or planning pregnancy during the study.
- History of mental illness, substance abuse, alcoholism, or other factors affecting safety or compliance.
- Diseases or symptoms secondary to tumors that increase medical risk or survival uncertainty.
- Other diseases, treatments, or abnormalities that may interfere with study results or participation safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
Ruihua Xu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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