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Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

NCT04644068•AstraZeneca

View on ClinicalTrials.gov

Summary

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Detailed Description

This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 at the time of screening
•Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
•Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
•Life expectancy ≥ 12 weeks
•Progressive cancer at the time of study entry
•Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
•Adequate organ and marrow function as defined by the protocol.
•For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
•For Part A:
•\- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
+2 more criteria

Exclusion Criteria

•Treatment with any of the following:
•1. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
•2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
•3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
•4. Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
•Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.
•Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
•Receiving continuous corticosteroids at a dose of \>10 mg prednisone/day or equivalent for any reason.
•Major surgery within 4 weeks of the first dose of study treatment.
•Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
+20 more criteria

Locations (68)

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Houston, Texas, United States

Research Site

Heidelberg, Australia

Research Site

Melbourne, Australia

Research Site

Vancouver, British Columbia, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Key Dates

Start Date

November 12, 2020

Primary Completion Date

May 28, 2027

Completion Date

May 28, 2027

Last Updated

February 19, 2026

Enrollment

702

ACTUAL participants

Conditions

Ovarian CancerBreast CancerPancreatic CancerProstate CancerAdditional Indications Below for Module 4 and 5Non-small Cell Lung CancerColorectal CancerBladder CancerGastric CancerBiliary CancerCervical CancerEndometrial CancerSmall Cell Lung Cancer Only in Module 5

Interventions

AZD5305

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG

T- Dxd

DRUG

Dato-DXd

DRUG

Camizestrant

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors