New drug cocktail aims to shrink Hard-to-Treat cancers
NCT ID NCT04644068
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 4 times
Summary
This study tests an experimental drug called AZD5305, a PARP inhibitor, either alone or combined with other cancer drugs in people with advanced solid tumors (like ovarian, breast, pancreatic, and lung cancers). The goal is to see if the treatment is safe and can shrink tumors. About 702 participants will receive the drug in different doses and combinations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD5305 (a PARP inhibitor drug taken by mouth)
- What this could lead to
- If successful, this could provide a new treatment option for people with advanced solid tumors that have limited options.
- What could go wrong
- This is an early-phase trial, so the drug may not work or could cause serious side effects. It is also testing many combinations, so results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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702 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key 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) For Part B: \- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance). Key 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Boston, Massachusetts, 02114, United States
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Research Site
Boston, Massachusetts, 02215, United States
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Research Site
New York, New York, 10021, United States
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Research Site
Oklahoma City, Oklahoma, 73104, United States
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Research Site
Houston, Texas, 77030, United States
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Research Site
Heidelberg, 3084, Australia
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Research Site
Melbourne, 3000, Australia
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Research Site
Vancouver, British Columbia, V5Z 1K1, Canada
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Research Site
Toronto, Ontario, M5G 2M9, Canada
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Research Site
Montreal, Quebec, H2X 0A9, Canada
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Research Site
Montreal, Quebec, H3T 1E2, Canada
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Research Site
Beijing, 100142, China
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Research Site
Changchun, 130021, China
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Research Site
Changsha, 410013, China
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Research Site
Chengdu, 610041, China
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Research Site
Chongqing, 400030, China
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Research Site
Guangzhou, 510060, China
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Harbin, 150081, China
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Jining, 272029, China
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Shandong, China
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Shanghai, 200025, China
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Research Site
Shanghai, 200032, China
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Research Site
Taiyuan, 030001, China
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Research Site
Wuhan, 430079, China
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Research Site
Xi'an, 710061, China
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Research Site
Brno, 656 53, Czechia
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Prague, 15006, Czechia
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Budapest, 1062, Hungary
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Research Site
Milan, 20132, Italy
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Research Site
Milan, 20141, Italy
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Research Site
Modena, 41125, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Research Site
Roma, 00168, Italy
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Research Site
Chūōku, 104-0045, Japan
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Research Site
Kōtoku, 135-8550, Japan
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Research Site
Bydgoszcz, 85-796, Poland
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Research Site
Gdansk, 80-214, Poland
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Research Site
Gdynia, 81-519, Poland
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Research Site
Grzepnica, 72-003, Poland
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Research Site
Lodz, 90-302, Poland
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Research Site
Torun, 87-100, Poland
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Research Site
Warsaw, 02-781, Poland
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Research Site
Moscow, 111123, Russia
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Research Site
Moscow, 115478, Russia
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Research Site
Moscow, 117997, Russia
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Research Site
Moscow, 143442, Russia
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Research Site
Seoul, 03080, South Korea
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Research Site
Seoul, 03722, South Korea
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Research Site
Seoul, 05505, South Korea
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Research Site
Seoul, 06351, South Korea
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Research Site
Barcelona, 08035, Spain
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Research Site
Madrid, 28040, Spain
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Research Site
Madrid, 28041, Spain
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Research Site
Madrid, 28050, Spain
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Research Site
Málaga, 29010, Spain
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Research Site
Pozuelo de Alarcón, 28223, Spain
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Research Site
Seville, 41013, Spain
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Research Site
Chernivtsі, 58013, Ukraine
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Research Site
Ivano-Frankivsk, 76018, Ukraine
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Research Site
Kyiv, 03022, Ukraine
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Research Site
Uzhhorod, 88000, Ukraine
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Research Site
Cambridge, CB2 0QQ, United Kingdom
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Research Site
Manchester, M20 4BX, United Kingdom
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Research Site
Oxford, OX3 7LE, United Kingdom
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Research Site
Sutton, SM2 5PT, United Kingdom
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