RECRUITING

A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies

Conditions

Breast Cancer Biliary Tract Carcinoma Ovarian Cancer Endometrial Cancer First In Human, antibody drug conjugate, cancer, solid tumour, Phase I

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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)

Quick Facts

Study Start:2021-10-18

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05123482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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) * Minimum body weight ≥ 30 kg. * Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer.	* 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. 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.

Inclusion Criteria

Exclusion 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
* 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)
* Minimum body weight ≥ 30 kg.
* Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer.

* 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.
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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

AstraZeneca Breast Cancer Study Locator Service

CONTACT

1-877-400-4656

az-bcsl@careboxhealth.com

Study Locations (Sites)

Research Site

Duarte, California, 91010

United States

Research Site

Irvine, California, 92618

United States

Research Site

Santa Monica, California, 90404

United States

Research Site

Santa Rosa, California, 95403

United States

Research Site

Sarasota, Florida, 34232

United States

Research Site

Shreveport, Louisiana, 71103

United States

Research Site

Baltimore, Maryland, 21231

United States

Research Site

Boston, Massachusetts, 02215

United States

Research Site

Saint Louis, Missouri, 63110

United States

Research Site

Albuquerque, New Mexico, 87109

United States

Research Site

Commack, New York, 11725

United States

Research Site

New York, New York, 10029

United States

Research Site

Charlotte, North Carolina, 28204

United States

Research Site

Pittsburgh, Pennsylvania, 15213

United States

Research Site

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-18

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-10-18

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

First In Human, antibody drug conjugate, cancer, solid tumour, Phase I

Additional Relevant MeSH Terms

Breast Cancer
Biliary Tract Carcinoma
Ovarian Cancer
Endometrial Cancer