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NCT05744427

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

725 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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A total of eight dose groups (Q3W, intravenous administration on the first day of each cycle) were designed in the dose escalation period. The dose groups were 1.0, 2.1, 4.2, 5.2, 6.3, 7.3, 8.4 and 10.5 mg/kg. The BOIN design, incorporating accelerated titration, was used, and the DLT observation period was set at 21 days.

The specific steps for implementing the BOIN design in the clinical trial are as follows:

1. Perform the accelerated titration as follows: Assign the first patient to dose level 1. If this patient does not develop dose-limiting toxicity (DLT), the second patient will be treated at the next higher dose level. Treat one patient at a time and continue the dose-escalation process until the first DLT is observed, or a second grade 2 toxicity occurs, or the highest dose is reached. Two more patients were then treated on the current dose. After that, follow steps 2 and 3 and take the number of cases in each group as 3 to treat the follow-up patients.
2. Assign the dose to the next group of subjects according to the dose rise and fall rule shown in the Bayesian Optimal interval (BOIN) decision table.
3. Repeat Step 2 until the set maximum sample size of 45 or the number of evaluable subjects treated at the current dose reaches 12 and the current decision is to maintain the current dose according to the rise and fall rule of the dose rise and fall decision table.

After the dose escalation period was completed, order preserving regression was used to determine MTD. This calculation can be achieved by "Select MTD" in BOIN online software (Zhou et al., 2020). Specifically, the dose whose toxicity rate is closest to the target toxicity rate estimated by isotropic regression is identified as the MTD. During the dose escalation period, the sponsor may, with the approval of the SMC, expand in the appropriate dose group based on the safety, efficacy and external data obtained during the dose escalation period, as long as the number of patients in the extended dose group is consistent with the total sample size during the dose expansion period. Safety monitoring can still be conducted based on the exclusion boundary in the decision table during dose expansion. The patient data of the extended dose group were not involved in the up-down dose decision and the isotonic regression calculation during the dose escalation period.

The Safety Monitoring Committee (SMC) will perform ongoing safety assessment during the dose escalation period. The safety data of each dose group should be reviewed and approved by the SMC before initiating the administration of the next dose group. If additional safety, efficacy, and PK data are required for a dose group by SMC resolution, subjects may continue enrollment in this dose group after completing the BOIN dose eescalation; If the SMC has decided that a dose group can proceed to the cohort extension phase, it is permitted to proceed directly to the cohort extension phase in that dose group. The composition and responsibilities of the SMC will be further detailed in the SMC Constitution.

The recommended dose for cohort expansion (RDE) will be determined by the SMC based on safety/tolerability, PK data, and preliminary antitumor activity, as well as other available data. RDE can be at or below the MTD; RDE may also vary for different indications.

The SMC and sponsor will evaluate the validity of the maximum tolerated dose (MTD) determined by the BOIN design based on data from clinical studies of dose escalation and dose extension, and determine whether it is necessary to explore the higher dose group of 12.6 mg/kg.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation and expansion period

in 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.

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiong Wu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Jian Zhang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Review additional registry numbers or institutional identifiers associated with this trial.

JSKN003-102

Identifier Type: -

Identifier Source: org_study_id

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Dose escalation and expansion period

JSKN003

cohort 1 in phase II

JSKN003

cohort 2 in phase II

JSKN003

cohort 3 in phase II

JSKN003

cohort 4 in phase II

JSKN003

cohort 5 in phase II

JSKN003

cohort 6 in phase II

JSKN003

cohort 7 in phase II

JSKN003

Interventions

JSKN003

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Responsible Party

Principal Investigators

Jiong Wu

Jian Zhang

Locations

Beijing Cancer Hospital

Beijing Friendship Hospital

Beijing Luhe Hospital

Hunan Cancer Hospital

Fujian Cancer Hospital

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Sun Yat-sen University Cancer Prevention Center

Run Run Shaw Hospital, Zhejiang University School of Medicine

The First Affiliated Hospital of Zhejiang University School of Medicine

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang Cancer Hospital

Affiliated Cancer Hospital of Harbin Medical University

Anhui Provincal Hospital

Shandong Cancer Hospital

Linyi City Cancer Hospital

Linyi City People's Hospital

The First Affiliated Hospital of Henan University of Science and Technology

The Second Affiliated Hospital of Nanchang University

Gulou Hospital Affiliated to Nanjing University School of Medicine

Jiangsu Cancer Hospital

Jiangsu Provincial People's Hospital

The First Affiliated Hospital of Nanjing Medical University/Jiangsu Provincial People's Hospital

Affiliated Cancer Hospital of Guangxi Medical University

Nantong Cancer Hospital

Affiliated Hospital of Qingdao University

Affiliated Cancer Hospital of Fudan University

Changhai Hospital

Fudan University Shanghai Cancer Center

Shanghai East Hospital

The Second Affiliated Hospital of Soochow University

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Zhongnan Hospital of Wuhan University

Xuzhou Central Hospital

The First Affiliated Hospital of Zhengzhou University

Countries

Other Identifiers

JSKN003-102