NCT07292402 JSKN022 in Subjects With Advanced Malignant Solid Tumors
| NCT ID | NCT07292402 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
| Condition | Advanced Malignant Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 225 participants in total. It began in 2025-10-23 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic/ pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.
Eligibility Criteria
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. Agree to provide Recently archived or fresh tumor tissue samples. 9. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures. 10. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose. 11. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol. 12. Adequate washout period of previous therapy before the first dose. Exclusion Criteria: 1. Complicated with other malignant tumors within 5 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk or tumor types with disease-free survival ≥ 5 years after radical treatment and extremely low recurrence/metastasis risk. 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, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration. 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. Gastrointestinal abnormalities with obvious clinical manifestations. 8. Active autoimmune diseases requiring systemic treatment within the past two years. 9. Significant serous effusion. 10. Uncontrolled infection. 11. Require regular glucocorticoid or immunosuppressive therapy. 12. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period. 13. Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors. 14. Previous occurrence of grade ≥ 3 immune-related adverse events during immunotherapy. 15. Toxicity of previous anti-tumor treatment has not fully or partially recovered. 16. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs. 17. Pregnant and/or lactating women, or planning to become pregnant during the study period. 18. 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. 19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and/or uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count \> 20×10⁹/L), cachexia manifestations, etc. 20. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07292402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07292402 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07292402 currently recruiting?
Yes, NCT07292402 is actively recruiting participants. Contact the research team at ruihxu@163.com for enrollment information.
Where is the NCT07292402 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07292402 clinical trial?
NCT07292402 is sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. The trial plans to enroll 225 participants.