JSKN022 for advanced malignant solid tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN022 in Subjects With Advanced Malignant Solid Tumors

This will test whether JSKN022 is safe and tolerable for adults with advanced unresectable or metastatic epithelial solid tumors who have exhausted or cannot receive standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07292402 on ClinicalTrials.gov

What this trial studies

This Phase I, open-label, first-in-human, multi-center trial gives escalating doses of the investigational drug JSKN022 to adults with advanced epithelial-derived solid tumors to define safety and tolerability. The study includes dose-escalation to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), along with serial sampling to characterize pharmacokinetics and pharmacodynamics. Antitumor activity will be monitored by RECIST 1.1 response assessments in patients with at least one measurable lesion. Participants must have ECOG 0–1, adequate organ function, and provide tumor tissue for biomarker analyses.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed unresectable or metastatic epithelial-derived malignant solid tumors, ECOG 0–1, measurable disease, adequate organ function, and who have progressed on, are intolerant of, or have no access to standard treatments are ideal candidates.

Not a fit: Patients with poor performance status (ECOG >1), very short expected survival, non-epithelial malignancies, or who are pregnant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, JSKN022 could become a new treatment option that shrinks tumors or slows disease progression for patients with advanced epithelial solid tumors who lack effective standard therapies.

How similar studies have performed: Antibody-drug conjugates and PD-L1 targeted approaches have shown activity in some cancers, but JSKN022 is first-in-human and its efficacy and safety are unproven.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ruihua Xu, Dr.

Conditions Advanced Malignant Solid Tumors; JSKN022; PD-L1; ITGB6; Antibody-Drug Conjugates