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

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Drug
  • PHASE1/PHASE2
  • AstraZeneca
  • 18 - 130 Years


Study Purpose

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.

Intervention

Drug : AZD5305

Drug : Paclitaxel

Drug : Carboplatin

Drug : T- Dxd

Drug : Dato-DXd

Drug : Camizestrant


Eligibility Requirements

info icon Age ≥ 18 at the time of screening

info icon Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..

info icon Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)

info icon Life expectancy ≥ 12 weeks

info icon Progressive cancer at the time of study entry

info icon Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B

info icon Adequate organ and marrow function as defined by the protocol.

info icon 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.

info icon For Part A:

info icon Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)

info icon For Part B:

info icon Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

info icon 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 treatmen

info icon Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.

info icon Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.

info icon Receiving continuous corticosteroids at a dose of \>10 mg prednisone/day or equivalent for any reason.

info icon Major surgery within 4 weeks of the first dose of study treatment.

info icon 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.

info icon Any history of persisting (\> 2 weeks) severe pancytopenia due to any cause

info icon 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.

info icon patient with known predisposition to bleeding (e.g., active peptic ulceration, recent \[within 6 months\] haemorrhagic stroke, proliferative diabetic retinopathy).

info icon Cardiac conditions as defined by the clinical study protocol

info icon 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 screenin

info icon Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

info icon 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

info icon Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).

info icon Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.

info icon other module-specific criteria may apply

Recruiting status

Recruiting

Estimated enrollment

804

 
Study start date

Nov 12, 2020

Study end date

Mar 03, 2027

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1/PHASE2

Allocation

Non Randomized

 

Sponsor:

AstraZeneca

Collaborator:

N/A

Investigator:

Timothy Yap

NCT04644068

Clinic Location Investigator Distance RECRUITING STATUS Contact