A phase I dose finding study of oral LTT462 in adult patients with advanced solid tumors harboring MAPK pathway alterations - A phase I clinical study with investigational compound LTT462 in adult patients with specific advanc

OVARTIS PHARMA SERVICES AG0 个研究点目标入组 65 人开始时间: 2020年11月4日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•-Patient (male or female) =12 years of age
•- ECOG (Eastern Cooperative Oncology Group) performance status =1
•- Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy
•exists, is tolerated or appropriate.
•-Patients must have a site of disease amenable to biopsy and be a
•candidate for tumor biopsy. Patients must be willing to undergo a new
•tumor biopsy at screening/baseline and during therapy.
•- Patients must be willing to undergo study required biopsies.
•- Presence of at least one measurable lesion according to RECIST v1.1.
•- Documented MAPK Pathway alteration
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•-- Prior treatment with ERK inhibitors.
•- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
•- Any medical condition that would, in the investigator’s judgment, prevent the patient’s participation in the clinical study due to
•safety concerns or compliance with clinical study procedures.
•- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the
•duration of the study.
•- Clinically significant cardiac disease
•Other protocol-defined exclusion criteria may apply

发起方