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JSKN033 in Chinese Subjects with Advanced Malignant Tumors | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

JSKN033 in Chinese Subjects with Advanced Malignant Tumors

Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors

NCT06770881•Jiangsu Alphamab Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be able to understand informed consent form, voluntarily participate and sign informed consent form.
•2. Age ≥18 year (at the time consent is obtained), male or female.
•3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
•4. Has a Life expectancy ≥3 months.
•5. Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
•6. Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
•7. Must have adequate organ function prior to the start of JSKN033.
•8. Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Exclusion Criteria

•1. Has clinically active brain metastases.
•2. Previously received any other investigational drug within 28 days prior to enrollment.
•3. Previously received local palliative treatment within 14 days prior to enrollment.
•4. Previously received major surgeries within 28 days prior to enrollment.
•5. Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
•6. Previously received live vaccine within 28 days prior to enrollment.
•7. Previously received antibody conjugate drug with topoisomerase I inhibitor.
•8. Has a history of other primary malignant tumors within 5 years prior to enrollment.
•9. Has uncontrolled comorbidities as specified by the protocol.
•10. Has a 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 period.
+6 more criteria

Key Dates

Start Date

January 15, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

January 13, 2025

Enrollment

430

ESTIMATED participants

Conditions

Advanced Malignant Tumors

Interventions

JSKN033

DRUG

Contacts

XiaoHua Wu, MD

CONTACT

02134778299 wu.xh@fudan.edu.cn

Jian Zhang, MD

CONTACT

02134778299 syner2000@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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JSKN033 in Chinese Subjects with Advanced Malignant Tumors

Inclusion Criteria

Exclusion Criteria

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