Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

Titre officiel

A Phase 1a/1b Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumours

Sommaire:

L’objectif de cette étude est de déterminer l’innocuité et l’efficacité du médicament à l’étude, le LY3537982, chez les patients atteints d’un cancer présentant une mutation génétique spécifique (KRAS G12C). Les patients doivent avoir déjà reçu ou ne pas avoir pu tolérer le traitement standard. L’étude durera environ deux ans.

Description de l'essai

Primary Outcome:

• Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy
• Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents

• To assess preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Objective response rate (ORR)
• To assess the preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Duration of Response (DOR)
• To assess the preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Best Overall Response (BOR)
• To assess the preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Time to response (TTR)
• To assess the preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Disease control rate (DCR)
• To assess the preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Progression-free survival (PFS)
• To assess the preliminary antitumour activity of LY3537982 when administered alone or in combination with other investigational agents: Overall survival (OS)
• To characterize the pharmacokinetics (PK) properties of LY3537982: Area under the plasma concentration versus time curve (AUC)
• To characterize the PK properties of LY3537982: Maximum drug concentration (Cmax)

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability, and preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumours.

This study will be conducted in 2 parts, Part 1a is a dose escalation and Part 1b is a dose expansion. Part 1a will establish a recommended Phase 2 dose. Part 1b will have multiple arms of either monotherapy or in combination with other drugs.

KRAS G12C mutations will be identified through standard of care testing.

Voir cet essai sur ClinicalTrials.gov