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
AstraZeneca
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
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
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Core Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study. * Participant must be ≥ 18 years at the time of signing the informed consent. * Willing to provide adequate archival an…
Interventions
- DrugAZD5335
IV Antibody-drug conjugate
- DrugSaruparib (AZD5305)
Oral PARP inhibitor
- DrugBevacizumab
IV Monoclonal antibody
- DrugCarboplatin
IV Alkylating agent
- DrugAZD9574
Oral PARP inhibitor
Locations (60)
- Research SiteDuarte, California
- Research SiteIrvine, California
- Research SiteLa Jolla, California
- Research SiteAurora, Colorado
- Research SiteLouisville, Kentucky
- Research SiteBoston, Massachusetts