A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors.
Status:
Completed
Trial end date:
2020-04-03
Target enrollment:
Participant gender:
Summary
This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811
at increasing doses in patients with advanced solid tumours and for whom no standard of care
exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a dose
expansion phase (Part B). During Part A, the dose-escalation phase, patient enrolment will
proceed according to a 3+3 design where the maximum tolerated dose (MTD) or the recommended
Phase II dose (RP2D) could be identified. The study will also characterize the
pharmacokinetic (PK) profile of AZD2811 and will explore the potential biological activity by
assessing anti-tumour activity in patients. Part B will further explore PK parameters,
safety, tolerability, and preliminary anti-tumour activity of the AZD2811 RP2D as monotherapy
(Group 1) in patients with relapsed/refractory SCLC.