Study of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies - PETRA

Study identifier:D9720C00001

ClinicalTrials.gov identifier:NCT04644068

EudraCT identifier:2020-002688-77

CTIS identifier:N/A

Recruiting

Official Title

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies

Medical condition

ovarian cancer, Small cell lung cancer only in module 5

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD5305, Paclitaxel, Carboplatin, T- Dxd, Dato-DXd, Camizestrant

Sex

All

Estimated Enrollment

804

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 12 Nov 2020
Estimated Primary Completion Date: 15 Dec 2026
Estimated Study Completion Date: 15 Dec 2026

Study design

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

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria