A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors

NCT 04801095

Brief Summary

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.

Intervention / Treatment 

  • Drug: WM-S1-030

Inclusion Criteria

  1. Aged ≥18 years.
  2. Able and willing to sign the informed consent form (ICF).
  3. Have at least 1 evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  4. Have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor which has progressed after treatment with standard therapies and for which no effective standard therapy is available or patient has refused, has a contraindication, or is intolerant to standard therapies.
  5. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  6. Must have archived frozen tissue available (collected within 3 months before screening) or consent to a pre-treatment biopsy.
  7. Must be willing to consent to up to 2 on-treatment biopsies.
  8. Have a life expectancy of at least 12 weeks.
  9. Have adequate hematological functions and blood coagulation.
  10. Have adequate hepatic function at screening.
  11. Have adequate renal function at screening.
  12. QT interval corrected for heart rate using Fridericia’s method ≤470 msec.
  13. Agree to abide by contraception requirements.
  14. Body mass index between 18 and 35 kg/m2 (exclusive)

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