NCT05797168

Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 506 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Ovarian Cancer
• Lung Adenocarcinoma
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	AZD5335	IV Antibody-drug conjugate
DRUG	Saruparib (AZD5305)	Oral PARP inhibitor
DRUG	Bevacizumab	IV Monoclonal antibody
DRUG	Carboplatin	IV Alkylating agent
DRUG	AZD9574	Oral PARP inhibitor

Timeline

• Start date: 2023-06-05
• Primary completion: 2028-01-06
• Completion: 2028-01-06
• First posted: 2023-04-04
• Last updated: 2026-03-02

Locations

60 sites across 12 countries: United States, Australia, Canada, China, Germany, Israel, Japan, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study