Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumours

Titre officiel

Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumours

Sommaire:

L’objectif principal de cette étude est d’évaluer l’innocuité et la tolérance du RP-6306 chez des patients présentant une tumeur solide au stade avancé admissible, de déterminer la dose maximale tolérée (DMT) et d’évaluer l’activité anti-tumorale préliminaire.

Description de l'essai

Primary Outcome:

  • Safety and Tolerability of RP-6306 in patients with advanced solid tumours as assessed by NCI CTCAE v5.0
  • To define the MTD of RP-6306 monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
  • Safety and Tolerability of RP-6306 in combination with RP-3500 in patients with advanced solid tumours as assessed by NCI CTCAE v5.0
  • To define the MTD of RP-6306 in combination with RP-3500, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
Secondary Outcome:
  • To assess the plasma concentrations of RP-6306 monotherapy in the fasted and fed states.
  • To assess the correlation between RP-6306 dose (mg) and degree of inhibition of phospho-CDK1 signal by immunohistochemistry.
  • To assess the percent of patients with a response to RP-6306 monotherapy per RECIST v1.1 criteria.
  • To assess the correlation between RP-6306 and RP-3500 dose (mg) and degree of gamma-H2AX induction by immunohistochemistry.
  • To assess the percent of patients with a response to RP-6306 and RP-3500 per RECIST v1.1 criteria.
Phase 1, multi-centre, open-label, dose-escalation study to: Evaluate the safety profile and MTD of RP-6306 alone and in combination with RP-3500 when administered orally to establish the recommended Phase 2 dose and schedule Characterize the PK and pharmacodynamics of RP-6306 alone and in combination with RP-3500 Assess preliminary anti-tumour activity associated with RP-6306 alone and in combination with RP-3500

Voir cet essai sur ClinicalTrials.gov

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