RecruitingPhase 1

SKB445 for Injection in Solid Tumors

China126 participantsStarted 2025-02-05

Plain-language summary

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. At the time of signing the ICF: age between 18 -75 years, male or female.
✓. subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
✓. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
✓. Expected survival ≥ 3 months.
✓. Subjects with adequate organ and bone marrow function confirmed by laboratory results
✓. Subjects of childbearing potential (male or female) must use effective medical contraception during the study
✓. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion criteria

✕. Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
✕. Has had major surgery within 4 weeks prior to the first dose.
✕. Has known history of allergy to any component of SKB445 or SKB445.
✕. Has a known previous or concurrent other malignancies within 3 years prior to first dose.
✕. Presence of active central nervous system (CNS) metastases.
✕. Has uncontrolled or severe cardiovascular disease.
✕. Has uncontrolled systemic diseases.
✕. Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.

What they're measuring

Number of subjects achieving Dose-limiting toxicity (DLT)

Timeframe: From date of initial dose until up to 21 days for treatment

Trial details

NCT IDNCT06826040

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Xin Li

086-010-58302512 lixin@kelun.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials