Study of AZD9574 as monotherapy and in combination with anti-cancer agents in participants with advanced solid malignancies - CERTIS1

Study identifier:D8410C00001

ClinicalTrials.gov identifier:NCT05417594

EudraCT identifier:2021-006227-17

CTIS identifier:2023-504984-17-00

Recruiting

Official Title

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)

Medical condition

Advanced solid malignancies

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD9574, Temozolomide, [11C]AZ1419 3391, Datopotamab Deruxtecan (Dato-DXd), Trastuzumab Deruxtecan (T-DXd)

Sex

All

Estimated Enrollment

490

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 24 Jun 2022
Estimated Primary Completion Date: 12 Jan 2026
Estimated Study Completion Date: 12 Jan 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria