Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors
Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN003 in Chinese Subjects With Advanced Solid Tumors
1 other identifier
interventional
725
1 country
34
Brief Summary
This is an open, multicenter study of phase I/II in Chinese subjects with unresectable locally advanced/metastatic solid tumors. It is divided into the dose escalation period and the cohort expansion period. A total of 8 dose groups (Q3W on the first day of intravenous administration) were designed in the dose escalation period. The initial dose was 1.0mg/kg administered Q3W, with a DLT observation period of 21 days. In the dose expansion phase, 7 cohorts were established.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2023
Typical duration for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 2, 2026
January 1, 2026
3.4 years
January 10, 2023
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
DLT (dose escalation period) in phase 1.
Incidence of dose-limiting toxicity (DLT) in the dose escalation period
Up to 12 months
Maximum Tolerated Dose (MTD) or RP2D in phase 1。
MTD (Maximum tolerated Dose) is the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate based on the BOIN Design
Up to 12 months
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events in phase 1.
TEAE and SAE were graded according to CTCAE 5.0
Throughout the duration of the study, approximately 2 years
Objective Response Rate (ORR) in phase 2
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
Throughout the duration of the study, approximately 2 years
Secondary Outcomes (8)
Clinical benefit rates (CBR)
Throughout the duration of the study, approximately 2 years
Progression Free Survival (PFS)
Throughout the duration of the study, approximately 2 years
Cmax of JSKN003
Throughout the duration of the study, approximately 2 years
Tmax of JSKN003
Throughout the duration of the study, approximately 2 years
AUC of JSKN003
Throughout the duration of the study, approximately 2 years
- +3 more secondary outcomes
Study Arms (8)
Dose escalation and expansion period
EXPERIMENTALin dose escalation and expansion period，total 8 dose groups were designed. Subjects will be give dose 1.0, 2.1, 4.2, 5.2, 6.3, 7.3, 8.4 and 10.5 mg/kg Q3W based on DLT results.
cohort 1 in phase II
EXPERIMENTALcohort 2 in phase II
EXPERIMENTALcohort 3 in phase II
EXPERIMENTALcohort 4 in phase II
EXPERIMENTALcohort 5 in phase II
EXPERIMENTALcohort 6 in phase II
EXPERIMENTALcohort 7 in phase II
EXPERIMENTALInterventions
JSKN003 should be administered intravenously on the first day of each 3-week cycle.
Eligibility Criteria
You may qualify if:
- 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;
- ECOG score 0 or 1, expected survival ≥12 weeks;
- Unresectable locally advanced or metastatic solid tumors with pathologic documented confirmation.
- 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.
- Agrees to provide adequate paraffin sections or fresh tissue specimens of the tumor for testing;
- Laboratory tests within 7 days or cardiac ultrasound within 28 days prior to the first dose meet the protocol criteria.
- Adequate washout from prior therapy prior to the first dose.
- 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);
You may not qualify if:
- Subjects with untreated active brain metastases or meningeal metastases;
- History of other primary malignant tumors;
- Previously received topoisomerase I inhibitor antibody conjugate drug;
- Has uncontrolled comorbidities as specified by the protocol；
- 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;
- 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.;
- Toxicity from previous antitumor therapy has not resolved to Grade 1 or lower as defined by NCI-CTCAE v5.0.
- 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;
- Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient in the JSKN003 drug formulation.
- History of trastuzumab-induced anaphylaxis (Grade ≥3), angioedema, or severe hypotension.
- 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.
- Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Beijing Cancer Hospital
Beijing, China
Beijing Friendship Hospital
Beijing, China
Beijing Luhe Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Sun Yat-sen University Cancer Prevention Center
Guangzhou, China
Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Affiliated Cancer Hospital of Harbin Medical University
Ha’erbin, China
Anhui Provincal Hospital
Hefei, China
Shandong Cancer Hospital
Jinan, China
Linyi City Cancer Hospital
Linyi, China
Linyi City People's Hospital
Linyi, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Gulou Hospital Affiliated to Nanjing University School of Medicine
Nanjing, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Provincial People's Hospital
Nanjing, China
The First Affiliated Hospital of Nanjing Medical University/Jiangsu Provincial People's Hospital
Nanjing, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, China
Nantong Cancer Hospital
Nantong, China
Affiliated Hospital of Qingdao University
Qingdao, China
Affiliated Cancer Hospital of Fudan University
Shanghai, China
Changhai Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai East Hospital
Shanghai, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Xuzhou Central Hospital
Xuzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jiong Wu
Fudan University
- PRINCIPAL INVESTIGATOR
Jian Zhang
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2023
First Posted
February 27, 2023
Study Start
March 15, 2023
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01