Study identifier:D8990C00001
ClinicalTrials.gov identifier:NCT05797168
EudraCT identifier:N/A
CTIS identifier:N/A
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
ovarian cancer
Phase 1/2
No
AZD5335, Saruparib (AZD5305), Bevacizumab, Carboplatin
All
396
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5335 administered either as monotherapy or in combination with other anti-cancer agents in participants with advanced solid malignancies
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Module 1: AZD5335 Monotherapy AZD5335 Monotherapy | Drug: AZD5335 IV Antibody-drug conjugate Other Name: None |
Experimental: Module 2: AZD5335 + Saruparib AZD5335 + Saruparib | Drug: AZD5335 IV Antibody-drug conjugate Other Name: None Drug: Saruparib (AZD5305) Oral PARP inhibitor Other Name: AZD5305 |
Experimental: Module 3: AZD5335 + Bevacizumab AZD5335 + Bevacizumab | Drug: Bevacizumab IV Monoclonal antibody Other Name: Avastin |
Experimental: Module 4: AZD5335 + Carboplatin +/- Bevacizumab AZD5335 + Carboplatin +/- Bevacizumab | Drug: Bevacizumab IV Monoclonal antibody Other Name: Avastin Drug: Carboplatin IV Alkylating agent Other Name: Paraplatin |