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Study of AZD5305 Alone and with Other Cancer Drugs for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for advanced solid tumors, which are types of cancer that have spread beyond their original location. The study will explore the effects of a new medication called AZD5305, which is taken as a film-coated tablet. This medication will be tested both on its own and in combination with other anti-cancer drugs. The purpose of the study is to assess the safety and tolerability of AZD5305 in patients with advanced cancer.

Participants in the study will receive AZD5305 either alone or alongside other treatments such as DS-8201a (also known as trastuzumab deruxtecan), camizestrant, and datopotamab deruxtecan. These additional treatments are designed to target specific proteins in cancer cells, potentially enhancing the effectiveness of the therapy. Some patients may also receive a placebo as part of the study. The study will involve regular monitoring to ensure the safety of participants and to gather information on how the body processes these medications.

The trial will take place over several years, with participants undergoing various assessments to monitor their health and the impact of the treatments. These assessments will include physical examinations and laboratory tests to track any changes in the body. The study aims to provide valuable insights into the potential benefits and risks of using AZD5305 and its combinations in treating advanced solid tumors.

1 joining the study

Upon joining the study, the patient will provide written consent. This is a formal agreement to participate in the trial and allows for study-specific procedures, sampling, and analyses to be conducted.

2 initial assessment

An initial assessment will be conducted to confirm the patient’s eligibility. This includes checking organ and marrow function, performance status, and life expectancy. A tumor specimen may be required for certain parts of the study.

3 treatment phase

The patient will receive AZD5305 as a film-coated tablet taken orally. The dosage and frequency will be determined by the study protocol.

In combination therapy, the patient may also receive other medications such as trastuzumab deruxtecan or paclitaxel, administered through intravenous infusion. The specific combination and schedule will depend on the study module.

4 monitoring and follow-up

Throughout the trial, the patient’s health will be monitored through regular physical examinations, laboratory tests, and imaging studies. This is to assess the safety and tolerability of the treatment.

The patient’s response to the treatment will be evaluated using criteria such as changes in tumor size and other relevant biomarkers.

5 completion of the study

Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall effects of the treatment. This includes a review of any side effects experienced and the overall response to the therapy.

Who Can Join the Study?

  • Provide signed and dated written consent before any study procedures, sampling, and analyses.
  • Male patients must use a condom with spermicide with all sexual partners from the start of the study to about 6 months after the last dose of the study drug.
  • Have proper organ and bone marrow function as defined by the study protocol.
  • For certain parts of the study, providing a sample of the tumor tissue is required, if available, unless stated otherwise.
  • Other specific criteria may apply depending on the study module.
  • Be at least 18 years old at the time of screening.
  • Have confirmation of advanced cancer that is suitable for the study treatment and meets specific criteria for the study module.
  • Have an Eastern Cooperative Oncology Group Performance status (ECOG) of 0-2, which means being able to carry out daily activities with no significant decline in the last 2 weeks.
  • Have a life expectancy of at least 12 weeks.
  • Have cancer that is getting worse at the time of joining the study.
  • Have a disease that can be measured or evaluated as defined in specific criteria for different parts of the study.
  • Female patients who can have children must have a negative pregnancy test at screening and before each treatment cycle, and must use at least one highly effective birth control method plus a barrier method.
  • Female patients must not breastfeed and must not donate or retrieve eggs for their own use from the start of the study to about 6 months after the last dose of the study drug.

Who Cannot Join the Study?

  • Patients who have a medical condition other than Advanced Solid Tumors cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care, cannot participate.
  • Patients who do not meet the specific health requirements set by the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Orszagos Onkologiai Intezet Budapest Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Instytut Msf Sp. z o.o. Lodz Poland
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
University Hospital Olomouc Olomouc Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Shjxckzjdu Efzdsln Budapest Hungary
Sgrirgvq Pvvownvce Sjy z opgn Gdynia Poland
Mxth Mwyfvpd Ceizgy Tvojc Torun Poland
Nlkgtcfhhfkj Zabaxj Oyulog Zygzfuudac Iuuosgeniue Mvcysqve Grzepnica Poland
Fpgehwra nyalmbcij Mvuwv a Hnnzqeg Prague Czechia
Nekexvac Icqnkwcd Oqqtbsnmh Ixe Mnolr Sotostjekksxltkrngcextrdydzp Iafyuefo Bzhqqwjn Cracow Poland
Uutgwclwnwmknr Cwuevox Kvytkmrbx Gdansk Poland
Hvfcsqqg Vcnx dsdkhtcp Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.04.2024
Hungary Hungary
Not recruiting
15.04.2024
Italy Italy
Not recruiting
15.04.2024
Poland Poland
Not recruiting
15.04.2024
Spain Spain
Not recruiting
15.04.2024

Trial locations

Investigated drugs:

AZD5305 is an experimental medication being studied for its potential to treat advanced solid tumors. It is being tested to see how safe and tolerable it is when used alone and in combination with other cancer-fighting drugs. The study aims to understand how the body processes this medication and its effects on the cancer cells.

Investigated diseases:

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body through the bloodstream or lymphatic system. The progression of these tumors can lead to symptoms such as pain, swelling, or dysfunction of the affected organ. The specific symptoms and progression depend on the tumor’s location and the organs involved. Advanced solid tumors often require comprehensive management to address the complex challenges they present.

Trial ID:
2022-502856-29-00
Protocol code:
D9720C00001
NCT ID:
NCT04644068
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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