A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors.

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.

Timeline

Start

2015-10-28

Primary completion

2020-02-07

Completion

2020-04-03

Publications

• Johnson ML, Fabbri G, Ciardullo C, Wang JS, Falchook GS, Jones S, Strickland D, Sands J, Gay CM, Cardnell RJ, Tobalina L, Willis SE, Rodriguez-Canales J, Nikolaou M, Jones EV, Schalkwijk S, Sainsbury L, MacDonald A, Overend P, Kennedy C, Pease JE, Szekeres P, Cosaert J, Burris H 3rd, Byers LA. Treatment monitoring by biomarker analysis in a Phase I dose-expansion study of AZD2811 for relapsed/refractory small-cell lung cancer. Br J Cancer. 2026 Jun;134(11):1592-1604. doi: 10.1038/s41416-026-03414-0. Epub 2026 Apr 3.
• Johnson ML, Wang JS, Falchook G, Greenlees C, Jones S, Strickland D, Fabbri G, Kennedy C, Elizabeth Pease J, Sainsbury L, MacDonald A, Schalkwijk S, Szekeres P, Cosaert J, Burris H 3rd. Safety, tolerability, and pharmacokinetics of Aurora kinase B inhibitor AZD2811: a phase 1 dose-finding study in patients with advanced solid tumours. Br J Cancer. 2023 May;128(10):1906-1915. doi: 10.1038/s41416-023-02185-2. Epub 2023 Mar 4.

Drugs

Indications