Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation Trial of KGX101 Administered as a Monotherapy to Patients With Advanced or Metastatic Solid Tumors
This is a first-in-human, multicenter, Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of KGX101, a tumor-activated interleukin 12 prodrug, as monotherapy in patients with advanced or metastatic solid tumors.
This study will enrol a maximum of 27 participants depending on the number of dose escalations needed. This study will assess the safety and tolerability of KGX101 monotherapy with a modified accelerated titration and a standard 3+3 dose escalation design to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). The total duration of modified accelerated titration period participation for each participant will be 70 days, including a 28-day screening, a 28-day DLT assessment and a 14-day washout. Dose escalation period, the total duration of participation for each participant will vary depending on events outcome. The participations will receive KGX101 intravenous infusion every 3 weeks at assigned escalating dose until disease progression or discontinuation criterion is met. ;
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|---|---|---|---|
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