SKB518 treatment for adults with advanced solid tumors

A Phase 1, Multicenter, Open-label First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors

This tests SKB518, an experimental injectable drug, in adults with advanced or metastatic solid tumors that have progressed after or are ineligible for standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, China)
• Trial ID: NCT06428331 on ClinicalTrials.gov

What this trial studies

This first-in-human, open-label Phase 1 dose-escalation study gives SKB518 by injection to adults with advanced or metastatic solid tumors who have exhausted or are ineligible for standard therapies. The study's primary focus is on safety and tolerability, with secondary measures of pharmacokinetics, immunogenicity, and signs of antitumor activity, and dose decisions are guided by an mTPI-2 adaptive design. Eligible participants must have at least one RECIST v1.1–measurable lesion, ECOG 0–1, life expectancy of at least three months, and provide tumor tissue for biomarker testing. Early cohorts will determine the recommended dose range for later studies.

Who should consider this trial

Good fit: Adults (≥18) with advanced or metastatic solid tumors who have progressed on or cannot receive standard treatments, have ECOG performance status 0–1, at least one measurable lesion, and available tumor tissue are the intended candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), no measurable disease, inability to provide required tumor tissue, or who have effective standard treatment options available are less likely to benefit from this early-phase study.

Why it matters

Potential benefit: If SKB518 is safe and shows antitumor activity, it could offer a new treatment option for patients who have few or no effective standard therapies.

How similar studies have performed: Other first-in-human dose-escalation studies of novel oncology agents have sometimes shown early signals of activity but overall remain uncertain, so this approach is promising but largely unproven.

Eligibility criteria

Inclusion Criteria:

1. Subject must be at least 18 years of age at the time of signing the informed consent;
2. Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments.
3. Subjects able to provide tumor blocks or 8\~10 slides \[fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)\] before the first dose of study intervention for biomarkers testing.
4. At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6. Life expectancy of at least 3 months as assessed by the investigators.
7. Subjects with adequate organ and bone marrow function confirmed by laboratory results within 7 days prior to the first dose.
8. Has recovered from all toxicities from previous therapy with the exception of stable, chronic (\>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor.
9. Subjects of childbearing potential (male or female) must use effective medical contraception during the study until 6 months after the last dose.
10. Subjects must be able to provide documented voluntary informed consent.

Exclusion Criteria:

1. Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
3. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases.
4. Has serious and/or uncontrolled concomitant diseases.
5. Has known active tuberculosis.
6. Has known human immunodeficiency virus (HIV) infection that is not well controlled.
7. Has any active viral hepatitis, hepatitis B or hepatitis C.
8. Has had major surgery within 28 days prior to the first dose.
9. Has known allergy or hypersensitivity to SKB518, or the excipients of SKB518.
10. Has a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis that required steroids.
11. Clinically serious lung injuries caused by lung diseases.
12. History of documented severe dry eye syndrome.
13. Has a history of allogeneic tissue/solid organ transplant.
14. Has known uncontrollable effusion.
15. Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
16. Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or has received BCRP inhibitors within 2 weeks prior to the first dose.
17. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks; or who received any small molecular tyrosine kinase inhibitor, antitumor hormonal therapy, system immune-stimulator, or therapy with traditional Chinese medicines approved for antitumor treatment, etc. within 2 weeks before the first dose.
18. Has an active infection requiring systemic therapy.
19. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
20. Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of fist dose.
21. Before the first dose, the subject's condition deteriorates rapidly.
22. Has a known psychiatric or substance abuse disorders.
23. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

Where this trial is running

Shanghai, China

• Fudan University Shanghai Cancer Center — Shanghai, China, China (Recruiting)

Study contacts

• Study coordinator: Xiaoping Jin, PhD

Conditions Advanced Solid Tumors