A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor

NCT 05332574

Brief Summary

This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.

Intervention / Treatment 

  • Biological: GB263T

Inclusion Criteria

  1. ≥18 years of age.
  2. Subjects with histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options.
  3. Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  4. ECOG PS 0-1.
  5. An expected survival time is ≥3 months.
  6. Adequate organ function.
  7. Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.

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