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

Detailed criteria

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

Drug
Torvutatug samrotecan
IV Antibody-drug conjugate
Drug
Saruparib
Oral PARP inhibitor
Drug
Bevacizumab
IV Monoclonal antibody
Drug
Carboplatin
IV Alkylating agent
Drug
Palacaparib
Oral PARP inhibitor
Drug
Pembrolizumab
IV Biologic

Locations (60)

Research Site
Duarte, California
Research Site
Irvine, California
Research Site
La Jolla, California
Research Site
Aurora, Colorado
Research Site
Louisville, Kentucky
Research Site
Boston, Massachusetts