Actively Recruiting
To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2024-09-19
140
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension.
CONDITIONS
Official Title
To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects able to understand and voluntarily sign informed consent
- Age 18 years or older, male or female
- Histologically or cytologically confirmed advanced unresectable or metastatic epithelial malignancies failing or intolerant to previous standard therapies
- For AGA-positive NSCLC, presence of specific mutations (e.g., EGFR, ALK, ROS1) or confirmed previous test results
- Breast cancer patients with HER2 IHC 0 expression regardless of hormone receptor status
- At least one measurable lesion at baseline by RECIST 1.1 criteria
- Expected survival time of 3 months or more
- ECOG performance status 0 or 1
- Agreement to use effective contraception from consent until 24 weeks after last dose; negative pregnancy test for women of childbearing potential
- Adequate organ function within 7 days before randomization (specified bone marrow, liver, renal, coagulation, and heart function)
- Ability and willingness to comply with study visits, treatments, and tests
You will not qualify if you...
- Active symptomatic central nervous system metastases; stable brain metastases allowed if seizure-free >12 weeks without steroids and stable on MRI
- Use of investigational drugs within 28 days before dosing
- Antineoplastic therapy within 28 days or 5 half-lives before dosing, Chinese herbal medicines with antitumor effects within 14 days
- Local palliative treatment within 14 days before dosing
- Major surgery within 28 days before dosing; minor procedures allowed
- Gastrointestinal abnormalities with recent obstruction, perforation, fistula, abscess, or significant bleeding within specified timeframes
- Uncontrolled or recurrent moderate to massive serous effusions requiring frequent drainage
- Prior treatment with topoisomerase inhibitor antibody-drug conjugates
- History or presence of interstitial lung disease or noninfectious pneumonia requiring steroids
- Other malignancies within 5 years except certain treated or non-invasive cancers
- Uncontrolled infections including active HBV, HCV, HIV, tuberculosis, syphilis
- Uncontrolled comorbidities such as hypertension, heart failure, arrhythmias, or thromboembolic events within 6 months
- Unresolved toxicity from previous antineoplastic therapy greater than CTCAE grade 1 except stable grade 2
- History of allogeneic bone marrow or organ transplantation
- Prior allergic reactions to antibody drugs
- Severe eye diseases affecting corneal healing
- Pregnant or lactating women
- Any other conditions affecting safety or compliance as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
2
Sun Yat-sen Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
H
herui yao yaoherui, D.PH
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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