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Trial Title: To Evaluate the Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

NCT ID: NCT05744427

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: JSKN003
Description: JSKN003 should be given on the first day of administration every 3 weeks by intravenous drip.
Arm group label: Dose escalation and expansion period
Arm group label: cohort 1 in phase II
Arm group label: cohort 2 in phase II
Arm group label: cohort 3 in phase II
Arm group label: cohort 4 in phase II
Arm group label: cohort 5 in phase II

Summary: This is an open, multicenter study of stage I/II in Chinese subjects with unresectable locally advanced/metastatic solid tumors. It is divided into dose escalation period and cohort expansion period. A total of 9 dose groups (Q3W on the first day of intravenous administration every three weeks) were designed in the dose escalation period. The initial dose was 1.0mg/kg, Q3W, and the observation period of DLT was 21 days. In the dose expansion phase, 5 cohorts were set up.

Detailed description: A total of nine (Q3W, the first day of intravenous administration every three weeks) dose groups were designed in the dose escalation period. The dose groups were 1.0, 2.1, 4.2, 5.3, 6.3, 7.3, 8.4, 9.4 and 10.5 mg/kg, respectively. The BOIN design with accelerated titration was used, and the DLT observation period was 21 days. The specific steps for conducting a clinical trial using the BOIN design 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-climbing 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. Once MTDS have been identified and the maximum sample size of 45 patients has not been reached, sponsors may enroll up to 12 additional patients in the selected MTDS to obtain more information on the safety and efficacy of the selected dose. In the additional extension process, the cull boundary in the decision table is used for toxicity monitoring. The Safety Monitoring Committee (SMC) will conduct an ongoing safety assessment during the dose escalation period. The safety data of each dose group should be reviewed and decided by the SMC before starting the administration of the next dose group. If additional safety, efficacy, and PK data are required for a dose group by SMC resolution, subjects will be allowed to continue to be enrolled in this dose group after completing the BOIN dose increment; 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 (i.e. to Phase Ib). 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 the same dose level as MTD or at a lower dose level than MTD; Rdes may also be different for different indications.

Criteria for eligibility:
Criteria:
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 a+B72 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. Previous 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, bad fluid, etc.; 7. Toxicity of previous antitumor therapy did not return to class 1 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. Previous 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, etc.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Lin Shen

Facility:
Name: Beijing Friendship Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Banwei Cao

Facility:
Name: Beijing Luhe Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Dong Yan

Facility:
Name: Hunan Cancer Hospital

Address:
City: Changsha
Country: China

Status: Recruiting

Contact:
Last name: Dihong Tang

Facility:
Name: Fujian Cancer Hospital

Address:
City: Fuzhou
Country: China

Status: Recruiting

Contact:
Last name: An Lin

Facility:
Name: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Jieqiong Liu

Facility:
Name: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Qunxian Rao

Facility:
Name: Sun Yat-sen University Cancer Prevention Center

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Chunyan Lan

Facility:
Name: Affiliated Cancer Hospital of Harbin Medical University

Address:
City: Ha'erbin
Country: China

Status: Recruiting

Contact:
Last name: Qingyuan Zhang

Facility:
Name: Run Run Shaw Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Country: China

Status: Recruiting

Contact:
Last name: Xian Wang

Facility:
Name: The First Affiliated Hospital of Zhejiang University School of Medicine

Address:
City: Hangzhou
Country: China

Status: Recruiting

Contact:
Last name: Jian Ruan

Contact backup:
Last name: Xiaochen Zhang

Facility:
Name: The Second Affiliated Hospital of Zhejiang University School of Medicine

Address:
City: Hangzhou
Country: China

Status: Recruiting

Contact:
Last name: Jian Huang

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Country: China

Status: Recruiting

Contact:
Last name: Yaqing Chen

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Country: China

Status: Recruiting

Contact:
Last name: Jieer Ying

Facility:
Name: Anhui Provincal Hospital

Address:
City: Hefei
Country: China

Status: Recruiting

Contact:
Last name: Yueying Pan

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Country: China

Status: Recruiting

Contact:
Last name: Bo Liu

Facility:
Name: Linyi City Cancer Hospital

Address:
City: Linyi
Country: China

Status: Recruiting

Contact:
Last name: Zhen Li

Facility:
Name: Linyi City People's Hospital

Address:
City: Linyi
Country: China

Status: Recruiting

Contact:
Last name: Guixiang Weng

Contact backup:
Last name: Zhongmin Zhang

Facility:
Name: The First Affiliated Hospital of Henan University of Science and Technology

Address:
City: Luoyang
Country: China

Status: Recruiting

Contact:
Last name: Xinshuai Wang

Facility:
Name: The Second Affiliated Hospital of Nanchang University

Address:
City: Nanchang
Country: China

Status: Recruiting

Contact:
Last name: Anwen Liu

Facility:
Name: Gulou Hospital Affiliated to Nanjing University School of Medicine

Address:
City: Nanjing
Country: China

Status: Not yet recruiting

Contact:
Last name: Jia Wei

Facility:
Name: Jiangsu Cancer Hospital

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Bo Shen

Facility:
Name: Jiangsu Provincial People's Hospital

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Yongqian Su

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

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Yongmei Yin

Facility:
Name: Affiliated Cancer Hospital of Guangxi Medical University

Address:
City: Nanning
Country: China

Status: Recruiting

Contact:
Last name: Li Li

Facility:
Name: Nantong Cancer Hospital

Address:
City: Nantong
Country: China

Status: Recruiting

Contact:
Last name: Lei Yang

Facility:
Name: Affiliated Hospital of Qingdao University

Address:
City: Qingdao
Country: China

Status: Recruiting

Contact:
Last name: Wenfeng Li

Facility:
Name: Affiliated Cancer Hospital of Fudan University

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Xiaohua Wu

Facility:
Name: Changhai Hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Gang Jin

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: jian zhang, professor

Phone: +8618017312991
Email: syner2000@163.com

Facility:
Name: Shanghai East Hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Qun Li

Facility:
Name: The Second Affiliated Hospital of Soochow University

Address:
City: Suzhou
Country: China

Status: Recruiting

Contact:
Last name: Zhixiang Zhuang

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

Address:
City: Wuhan
Country: China

Status: Recruiting

Contact:
Last name: Yanxia Zhao

Facility:
Name: Zhongnan Hospital of Wuhan University

Address:
City: Wuhan
Country: China

Status: Recruiting

Contact:
Last name: Jing Dai

Facility:
Name: Xuzhou Central Hospital

Address:
City: Xuzhou
Country: China

Status: Recruiting

Contact:
Last name: Xiang Wang

Facility:
Name: The First Affiliated Hospital of Zhengzhou University

Address:
City: Zhengzhou
Country: China

Status: Recruiting

Contact:
Last name: Hong Zhong

Start date: March 15, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Agency class: Industry

Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05744427

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