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

Sponsor
AstraZeneca
Study ID
NCT05514132
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ceralasertib — DRUG
    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.
  • Durvalumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 23, 2022
Status verified
Mar 2026
Primary completion
Oct 20, 2023
Completion
Mar 31, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ceralasertib in Combination with Durvalumab
    This is a sequential group treatment/dose-escalation study with 2 cohorts with no masking.

Primary Outcome Measure

The number of subjects with dose-limiting toxicity, as defined in the protocol. [ Time Frame: From the first dose of study treatment Up to and including the end of cycle 1(each cycle is 28 days) . ]

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