New hope for advanced tumors: experimental drug JSKN003 enters human trials
NCT ID NCT05744427
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called JSKN003 in Chinese adults with advanced solid tumors that cannot be removed by surgery or have spread. The trial has two parts: first, finding the safest dose, and then expanding to see how well the drug shrinks tumors. About 725 participants will receive the drug intravenously every three weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 725 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is at least 18 years old, male or female, and willing to follow the study procedure on the date of signing the informed consent; 2. ECOG score 0 or 1, expected survival ≥12 weeks; 3. Unresectable locally advanced or metastatic solid tumors with pathologic documented confirmation. 4. Measurable lesions at baseline according to RECIST 1.1 criteria; If the subject has only one measurable lesion at baseline, the lesion area must not have received prior radiotherapy or there is evidence of significant progression after the end of radiotherapy. 5. Agrees to provide adequate paraffin sections or fresh tissue specimens of the tumor for testing; 6. Laboratory tests within 7 days or cardiac ultrasound within 28 days prior to the first dose meet the protocol criteria. 7. Adequate washout from prior therapy prior to the first dose. 8. A fertile female subject or a fertile male subject with fertile partner agrees to use highly effective contraception (annual failure rate less than 1%) from the time of initial dosing to 180 days after the end of dosing. Pregnancy test results must be negative for fertile female subjects within 7 days prior to initial administration (fertile women are defined as premenopausal women with no recorded tubal ligation or hysterectomy, or women who have been menopausal for less than 1 year); Exclusion Criteria: 1. Subjects with untreated active brain metastases or meningeal metastases; 2. History of other primary malignant tumors; 3. Previously received topoisomerase I inhibitor antibody conjugate drug; 4. Has uncontrolled comorbidities as specified by the protocol； 5. Past or current history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening; 6. Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.; 7. Toxicity from previous antitumor therapy has not resolved to Grade 1 or lower as defined by NCI-CTCAE v5.0. 8. Systemic corticosteroids (≥10 mg/ day of prednisone, or equivalent of other corticosteroids) or immunosuppressant therapy were required within 14 days prior to initial administration in this study; 9. Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient in the JSKN003 drug formulation. 10. History of trastuzumab-induced anaphylaxis (Grade ≥3), angioedema, or severe hypotension. 11. Subjects with gastrointestinal tumors who are known to have lost 10% or more of their body weight within three months prior to signing the informed consent form. 12. Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Fudan University
Shanghai, China
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Affiliated Cancer Hospital of Guangxi Medical University
Nanning, China
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Affiliated Cancer Hospital of Harbin Medical University
Ha’erbin, China
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Affiliated Hospital of Qingdao University
Qingdao, China
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Anhui Provincal Hospital
Hefei, China
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Beijing Cancer Hospital
Beijing, China
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Beijing Friendship Hospital
Beijing, China
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Beijing Luhe Hospital
Beijing, China
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Changhai Hospital
Shanghai, China
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Fudan University Shanghai Cancer Center
Shanghai, China
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Fujian Cancer Hospital
Fuzhou, China
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Gulou Hospital Affiliated to Nanjing University School of Medicine
Nanjing, China
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Hunan Cancer Hospital
Changsha, China
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Jiangsu Cancer Hospital
Nanjing, China
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Jiangsu Provincial People's Hospital
Nanjing, China
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Linyi City Cancer Hospital
Linyi, China
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Linyi City People's Hospital
Linyi, China
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Nantong Cancer Hospital
Nantong, China
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Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
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Shandong Cancer Hospital
Jinan, China
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Shanghai East Hospital
Shanghai, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
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Sun Yat-sen University Cancer Prevention Center
Guangzhou, China
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The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
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The First Affiliated Hospital of Nanjing Medical University/Jiangsu Provincial People's Hospital
Nanjing, China
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The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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The Second Affiliated Hospital of Nanchang University
Nanchang, China
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The Second Affiliated Hospital of Soochow University
Suzhou, China
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
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Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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Xuzhou Central Hospital
Xuzhou, China
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Zhejiang Cancer Hospital
Hangzhou, China
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Zhongnan Hospital of Wuhan University
Wuhan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors