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NCT05514132
PHASE1

A Study to Evaluate the Safety and Pharmacokinetics of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a Phase 1, open-label study of ceralasertib given in combination with durvalumab in Chinese participants with advanced solid tumours. In each cohort, a monotherapy lead-in period (Cycle 0, duration of 7 or 14 days), prior to dosing with durvalumab, is added to investigate the PK profile and safety/tolerability of ceralasertib in Chinese participants. This study is designed to investigate and characterise preliminary safety, tolerability, and PK of ceralasertib in DLT-evaluable Chinese participants

Official title: A Phase I, Multi-centre, Open-label, Dose Exploration Study to Assess the Safety and Tolerability of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2022-09-23

Completion Date

2026-03-31

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Ceralasertib

Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase, ATR, with good selectivity against other phosphatidylinositol 3-kinase-related kinase family members.

DRUG

Durvalumab

Durvalumab is a human mAb of the immunoglobulin G 1 kappa subclass that blocks the interaction of PD-L1 (but not PD-L2) with PD-1 on T cells and CD80 (B7.1) on immune cells.

Locations (2)

Research Site

Beijing, China

Research Site

Shandong, China