Spots Global Cancer Trial Database for A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors

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Trial Identification

Brief Title: A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors

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

Study ID: NCT06074497

Conditions

Advanced or Metastatic Solid Tumors

Interventions

Study Description

Brief Summary: 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.

Detailed Description: 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.