Phase I/IIa Study of AZD5335 as monotherapy and combination therapy in participants with solid tumors - FONTANA

Study identifier:D8990C00001

ClinicalTrials.gov identifier:NCT05797168

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors

Medical condition

ovarian cancer

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD5335, Saruparib (AZD5305), Bevacizumab, Carboplatin

Sex

All

Estimated Enrollment

396

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 05 Jun 2023
Estimated Primary Completion Date: 06 Jan 2028
Estimated Study Completion Date: 06 Jan 2028

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria