Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
NCT ID: NCT04644068
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
702 participants
INTERVENTIONAL
2020-11-12
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
* Module 1 (AZD5305 monotherapy)
* Module 2 (AZD5305 in combination with paclitaxel)
* Module 3 (AZD5305 in combination with carboplatin, with or without paclitaxel)
* Module 4 (AZD5305 in combination with T DXd)
* Module 5 (AZD5305 in combination with Dato-DXd).
* Module 6 (AZD5305 in combination with Camizestrant)
Modules 1 and 4 has 2 study parts: Part A consisting of dose-escalation cohorts and Part B, consisting of expansion cohorts. Modules 2, 3, 5 and 6 have only PART A.
TREATMENT
NONE
Study Groups
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Module 1: AZD5305 Monotherapy
AZD5305 Monotherapy
AZD5305
Oral PARP inhibitor
Module 2: AZD5305 + Paclitaxel
AZD5305 + Paclitaxel
AZD5305
Oral PARP inhibitor
Paclitaxel
IV Anti-microtubule agent
Module 3: AZD5305 + Carboplatin with or without Paclitaxel
AZD5305 + Carboplatin with or without Paclitaxel
AZD5305
Oral PARP inhibitor
Paclitaxel
IV Anti-microtubule agent
Carboplatin
IV Platinum chemotherapeutic
Module 4: AZD5305 + Trastuzumab Deruxtecan
AZD5305 + T- DXd
AZD5305
Oral PARP inhibitor
T- Dxd
IV Antibody-drug conjugate
Module 5 AZD5305 + Datopotamab Deruxtecan
AZD5305 + Dato-DXd
AZD5305
Oral PARP inhibitor
Dato-DXd
IV Antibody-drug conjugate
Module 6 AZD5305 + Camizestrant
AZD5305 + Camizestrant
AZD5305
Oral PARP inhibitor
Camizestrant
Oral SERD Molecule
Interventions
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AZD5305
Oral PARP inhibitor
Paclitaxel
IV Anti-microtubule agent
Carboplatin
IV Platinum chemotherapeutic
T- Dxd
IV Antibody-drug conjugate
Dato-DXd
IV Antibody-drug conjugate
Camizestrant
Oral SERD Molecule
Eligibility Criteria
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Inclusion Criteria
* 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)
For Part B:
\- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
Exclusion Criteria
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.
* Any history of persisting (\> 2 weeks) severe pancytopenia due to any cause
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
* patient with known predisposition to bleeding (e.g., active peptic ulceration, recent \[within 6 months\] haemorrhagic stroke, proliferative diabetic retinopathy).
* Cardiac conditions as defined by the clinical study protocol
* Other cardiovascular diseases as defined by any of the following:
1. Symptomatic heart failure,
2. uncontrolled hypertension,
3. hypertensive heart disease with significant left ventricular hypertrophy
4. acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
5. cardiomyopathy of any etiology
6. presence of clinically significant valvular heart disease
7. history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (\< 100 beats per minute) are permitted.
8. subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
9. transient ischaemic attack, or stroke within 6 months prior to screening
10. patients with symptomatic hypotension at screening
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305
* Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
other module-specific criteria may apply
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Yap
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
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Melbourne, , Australia
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Harbin, , China
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Jining, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Taiyuan, , China
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Wuhan, , China
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Xi'an, , China
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Brno, , Czechia
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Prague, , Czechia
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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Chūōku, , Japan
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Kōtoku, , Japan
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Grzepnica, , Poland
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Lodz, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pozuelo de Alarcón, , Spain
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Seville, , Spain
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Chernivtsі, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
Research Site
Uzhhorod, , Ukraine
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Cambridge, , United Kingdom
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Manchester, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
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References
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Illuzzi G, Staniszewska AD, Gill SJ, Pike A, McWilliams L, Critchlow SE, Cronin A, Fawell S, Hawthorne G, Jamal K, Johannes J, Leonard E, Macdonald R, Maglennon G, Nikkila J, O'Connor MJ, Smith A, Southgate H, Wilson J, Yates J, Cosulich S, Leo E. Preclinical Characterization of AZD5305, A Next-Generation, Highly Selective PARP1 Inhibitor and Trapper. Clin Cancer Res. 2022 Nov 1;28(21):4724-4736. doi: 10.1158/1078-0432.CCR-22-0301.
Related Links
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Breast Cancer Study Locator details (for US)
Other Identifiers
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2020-002688-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9720C00001
Identifier Type: -
Identifier Source: org_study_id
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