Study of AZD5305 as Monotherapy and with Anti-Cancer Agents in Patients with Advanced Solid Malignancies

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502856-29-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1067

Inclusion Criteria

Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses., Male patients must use a condom with spermicide with all sexual partners from screening to approximately 6 months after the last dose of AZD5305 IMP., 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., Other module specific criteria may apply., Age = 18 at the time of screening., Patients must have 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 with no deterioration in the previous 2 weeks., 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., Female subjects of childbearing potential: Must have negative pregnancy test result at screening and prior to each cycle administration of study treatment and must use at least one highly effective method of birth control plus a barrier method., Female subjects must not breastfeed and must not donate or retrieve ova for their own use, from screening to approximately 6 months after the last dose of study treatment with IMP.

Exclusion Criteria

Treatment with any of the following: a) Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment b) 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 c) Any other anticancer treatment within the time periods to the first dose of study treatment as indicated in the protocol d) Any live virus or bacterial vaccine within 28 days of the first dose of study treatment., Patients with any known predisposition to bleeding., Any of the following cardiac criteria; a) Mean resting corrected QT interval (QTcF) > 450 milliseconds or QTcF<340 milliseconds b) Any factors that increase the risk of QT prolongation, shortening or risk of arrhythmic events, congenital long or short QT syndrome, family history of long QT syndrome, familial short QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication c) Known to prolong or shorten the QT interval d) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG and clinically significant sinus node dysfunction not treated with pacemaker., Other cardiovascular diseases as defined by any of the following; a) Symptomatic heart failure b) Uncontrolled hypertension c) Hypertensive heart disease with significant left ventricular hypertrophy d) 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 e) Cardiomyopathy of any etiology f) Presence of clinically significant valvular heart disease g) History of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation/flutter and optimally controlled ventricular rate (<100 beats per minute) are permitted h) Transient ischaemic attack, or stroke within 6 months prior to screening i) 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)., Any concurrent therapy anti-cancer therapy or concurrent use of prohibited medications., Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements., Any condition that, in the investigator's opinion, would interfere with evaluation of the study treatment or interpretation of subject safety or study results., Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study., Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong and moderate inhibitors or inducers., Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site., Previous study treatment assignment in the present study., Uncontrolled intercurrent illness within the last 12 months., Pr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified