for people ages 18-130 (full criteria)
study started
estimated completion



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.

Official Title

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


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.


Ovarian Cancer Breast Cancer Pancreatic Cancer Prostate Cancer Additional Indications Below for Module 4 and 5 Non-small Cell Lung Cancer Small Cell Lung Cancer Colorectal Cancer Bladder Cancer Gastric Cancer Biliary Cancer Cervical Cancer Endometrial Cancer PARP inhibitor AZD5305, T-DXd, Enhertu, Trastuzumab Deruxtecan, Dato-DXd, Datopotamab Deruxtecan Lung Neoplasms Prostatic Neoplasms Pancreatic Neoplasms Ovarian Neoplasms Small Cell Lung Carcinoma Endometrial Neoplasms Paclitaxel Carboplatin AZD5305 T- Dxd Dato-DXd Module 1: AZD5305 Monotherapy Module 2: AZD5305 + Paclitaxel Module 4: AZD5305 + Trastuzumab Deruxtecan Module 5 AZD5305 + Datopotamab Deruxtecan


You can join if…

Open to people ages 18-130

  • 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).

You CAN'T join if...

  • Treatment with any of the following:
  • Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
  • 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
  • Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
  • 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 and moderate 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.
  • Cardiac conditions as defined by the clinical study protocol
  • Other cardiovascular diseases as defined by any of the following:
  • Symptomatic heart failure,
  • uncontrolled hypertension,
  • hypertensive heart disease with significant left ventricular hypertrophy
  • 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.
  • cardiomyopathy of any etiology
  • presence of clinically significant valvular heart disease
  • history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
  • subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
  • transient ischaemic attack, or stroke within 6 months prior to screening
  • . 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).

other module-specific criteria may apply


  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    Vancouver British Columbia V5Z 1K1 Canada


accepting new patients
Start Date
Completion Date
Phase 1/2 research study
Study Type
Expecting 715 study participants
Last Updated