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Evaluating the safety of JSKN003 in Chinese patients 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

Phase1; Phase2 Interventional Jiangsu Alphamab Biopharmaceuticals Co., Ltd · NCT05744427

This study is testing a new drug called JSKN003 to see if it's safe for Chinese patients with advanced solid tumors that can't be surgically removed.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment725 (estimated)
Ages18 Years and up
SexAll
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd Industry-sponsored
Drugs / interventionstrastuzumab, prednisone
Locations36 sites (Beijing and 35 other locations)
Trial IDNCT05744427 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase I/II study investigates the safety and tolerability of JSKN003 in Chinese subjects with unresectable locally advanced or metastatic solid tumors. The trial consists of a dose escalation phase with eight different dose levels administered intravenously every three weeks, followed by a cohort expansion phase. The Bayesian Optimal Interval (BOIN) design is utilized to determine the maximum tolerated dose (MTD) while monitoring for dose-limiting toxicities (DLTs). Participants will provide tumor specimens for testing and must meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable locally advanced or metastatic solid tumors and an ECOG score of 0 or 1.

Not a fit: Patients with resectable tumors or those who have not adequately recovered from prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.

How similar studies have performed: Other studies using similar dose escalation and BOIN design approaches have shown promise, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Beijing and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.