New hope for advanced cancer patients as experimental drug JSKN021 enters first human tests
NCT ID NCT07617727
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This early-stage study tests a new drug, JSKN021, in about 199 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety and find the best dose. Researchers will also look for signs that the drug shrinks tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 199 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Jining Medical College
RECRUITINGJining, Shandong, China
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, China
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Fujian Cancer Hospital
RECRUITINGFuzhou, Fujian, 350014, China
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Harbin Medical University Cancer Hospital
RECRUITINGHarbin, Heilongjiang, 150081, China
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Hubei Cancer Hospital
RECRUITINGWuhan, Hubei, 430079, China
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Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, China
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Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Tumor Hospital of Guangxi Medical University
RECRUITINGNanning, Guangxi, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, China
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Xuzhou Central Hospital
RECRUITINGXuzhou, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New injectable drug tested against Hard-to-Treat solid tumors
- Can an oral drug shrink advanced solid tumors?
- New drug combo targets Hard-to-Treat cancers
- New drug combo takes on advanced cancers
- Experimental injection trains immune cells inside the body to fight cancer
- New combo therapy takes on advanced cancers