First-in-human test of JSKN021 in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter phase 1 trial assessing safety, tolerability, and pharmacokinetics of JSKN021 in adults with advanced malignant solid tumors. The study will also explore early antitumor activity to see if the drug shows promise in this patient population. Eligible participants have measurable disease, adequate organ function, and may have limited or no remaining standard treatment options. Dosing will begin at a small level with careful monitoring for adverse effects. The trial is conducted at three Chinese cancer centers and is sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participate and sign the informed consent form.
2. Age ≥ 18 years old, male or female.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
4. Expected survival ≥ 3 months.
5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.
7. Adequate organ function.
8. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
9. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
11. Adequate washout period of previous therapy before the first dose.

Exclusion Criteria:

1. Complicated with other malignant tumors within 3 years before the first dose.
2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
7. Uncontrolled infection.
8. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
9. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
10. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
11. Pregnant and/or lactating women, or planning to become pregnant during the study period.
12. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Tumor Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Jiangsu Province Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jian Zhang, MD
• Email: syner2000@163.com
• Phone: 08602134778299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.