Breast Cancer Clinical Trial
Official title:
A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents
Status | Recruiting |
Enrollment | 340 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Age = 18 years - Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy. - Measurable disease per RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 - Life expectancy = 12 weeks - Adequate organ and marrow function as defined in the protocol For Sub-Study 1 Part A: • Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer For Sub-Study 1 Part B: - Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort: 1. Cohort B1 (Biliary Tract Cancer) 2. Cohort B2 (Ovarian Cancer) 3. Cohort B3 (Breast Cancer) 4. Cohort B4 (Endometrial Cancer) For Sub-Study 2 Part A: - Minimum body weight = 30 kg. - Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer. Exclusion Criteria: - Treatment with any of the following: 1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment 2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment 3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention: 1. Cytotoxic treatment: 21 days 2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter) 3. Biological products including immuno-oncology agents: 28 days - Spinal cord compression or a history of leptomeningeal carcinomatosis. - Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study. - Active infection including tuberculosis and HBV, HCV or HIV - History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. - Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses - Participants with any of the following cardiac criteria: 1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia. 2. Uncontrolled hypertension. 3. Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months. 4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening. 5. Symptomatic heart failure (NYHA class = 2). 6. Prior or current cardiomyopathy. 7. Severe valvular heart disease. 8. Mean resting QTcF > 470 msec. 9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age. Additional Exclusion Criteria for Part A Sub study 2 1. Thromboembolic event within 3 months before the first dose of study intervention. 2. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. 3. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. |
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | Clayton | |
Australia | Research Site | Melbourne | |
Australia | Research Site | Nedlands | |
Australia | Research Site | South Brisbane | |
Belgium | Research Site | Anderlecht | |
Belgium | Research Site | Leuven | |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
China | Research Site | Beijing | |
China | Research Site | Changsha | |
China | Research Site | Chongqing | |
China | Research Site | Guangzhou | |
China | Research Site | Kunming | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Italy | Research Site | Milan | |
Italy | Research Site | Modena | |
Italy | Research Site | Roma | |
Japan | Research Site | Chuo-ku | |
Japan | Research Site | Kashiwa | |
Japan | Research Site | Koto-ku | |
Japan | Research Site | Sunto-gun | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Netherlands | Research Site | Amsterdam | |
Poland | Research Site | Warszawa | |
Spain | Research Site | Barcelona | |
Spain | Research Site | L'Hospitalet de Llobregat | |
Spain | Research Site | Madrid | |
Spain | Research Site | Málaga | |
Spain | Research Site | Pamplona | |
Taiwan | Research Site | Tainan | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taoyuan | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Chiang Mai | |
United Kingdom | Research Site | Cambridge | |
United Kingdom | Research Site | Cardiff | |
United Kingdom | Research Site | London | |
United States | Research Site | Albuquerque | New Mexico |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Commack | New York |
United States | Research Site | Duarte | California |
United States | Research Site | Houston | Texas |
United States | Research Site | Irvine | California |
United States | Research Site | New York | New York |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Santa Monica | California |
United States | Research Site | Santa Rosa | California |
United States | Research Site | Sarasota | Florida |
United States | Research Site | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Australia, Belgium, Canada, China, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients with adverse events | Number of patients with adverse events by system organ class and preferred term | From time of Informed consent to 30 days post last dose (approximately 1 year). | |
Primary | The number of patients with serious adverse events | Number of patients with serious adverse events by system organ class and preferred term | From time of Informed consent to 30 days post last dose (approximately 1 year) | |
Primary | The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. | A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes pre-defined haematological and non-haematological toxicities. | From first dose of study treatment until the end of Cycle 1 (approximately 21 days). | |
Primary | The number of patients with changes from baseline laboratory findings, ECGs and vital signs | Description of laboratory findings and vital signs variables over time including change from baseline. | From time of informed consent to 30 days post last dose (approximately 1 year) | |
Secondary | Objective Response Rate (ORR) | The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). | From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years ) | |
Secondary | Duration of response (DoR) | The time from the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression. | From the first documented response to confirmed progressive disease or death ( approx. 2 years ) | |
Secondary | Progression free Survival (PFS) | The time from first dose until RECIST 1.1 defined disease progression or cessation of study treatment. | From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years ) | |
Secondary | Disease Control Rate at 12 weeks (DCR-12) | Percentage of patients with confirmed CR or PR or having SD maintained for >= 11 weeks from first dose (RECIST 1.1). | Measured from first dose until progression. For each patient, this is expected to be at 12 weeks | |
Secondary | Overall Survival (OS) | The time from the date of the first dose of study treatment until death due to any cause. | From first dose of AZD8205 to death ( approx. 2 years ) | |
Secondary | Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC) | Area under the plasma concentration-time curve | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax) | Maximum observed plasma concentration of the study drug | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max) | Time to maximum observed plasma concentration of the study drug | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Pharmacokinetics of AZD8205: Clearance | A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Pharmacokinetics of AZD8205: Terminal elimination half-life (t 1/2) | Terminal elimination half life. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Immunogenicity of AZD8205. | The number and percentage of participants who develop ADAs. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Sub Study 1: AZD8205 monotherapy Pharmacodynamics | To assess the intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered as a monotherapy. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) | |
Secondary | Sub Study 2: AZD8205 in combination with AZD2936 Pharmacodynamics | To assess the change in intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered in combination with rilvegostomig. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) |
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