BridgeMD
New treatment option for Breast Cancer
Official title A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
ClinicalTrials.gov ID: NCT05123482
What this study is testing
What is AZD8205?
AZD8205 is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
You likely can't join if
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
- 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...
- Any other anticancer treatment within the following time periods prior to the first dose of study intervention:
- Cytotoxic treatment: 21 days
- Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
See the full eligibility criteria
Who can join
- 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...
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Adequate bone marrow, hepatic, and renal function as defined in the protocol Additional For Sub-Study 1 Part A:
- Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer Additional For Sub-Study 1 Part B:
- Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:
- Cohort B1 (Biliary Tract Cancer)
- Cohort B2 (Ovarian Cancer)
- Cohort B3 (Breast Cancer)
- Cohort B4 (Endometrial Cancer)
- Cohort B5 (Squamous Non-Small Cell Lung Cancer) Additional 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, endometrial cancer or squamous non-small cell lung cancer. Additional For Sub-Study 3 Part A:
- Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).
- Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer. Additional For Sub-Study 4 Part A:
- Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).
- Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, endometrial cancer or squamous non-small cell lung cancer.
- Participants must have progressed following at least one but no more than 3 prior lines of treatment for metastatic or relapsed disease and have no satisfactory alternative treatment option as judged by the...
What rules you out
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
- 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
- Any other anticancer treatment within the following time periods prior to the first dose of study intervention:
- Cytotoxic treatment: 21 days
- Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
- 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:
- 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.
- Uncontrolled hypertension.
- Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.
- History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
- Symptomatic heart failure (NYHA class ≥ 2).
- Prior or current cardiomyopathy.
- Severe valvular heart disease.
- Mean resting QTcF \> 470 msec.
- 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.
- Patients with history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation) Additional Exclusion Criteria For Sub-Study 2...
- Thromboembolic event within 3 months before the first dose of study intervention - No longer applicable per amendment 7
- Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- History of organ transplant Additional Exclusion Criteria For Sub-Study 2 Part B
- Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.) Additional Exclusion Criteria For Sub-Study 3 Part A:
- Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers/inhibitors.
- Any history of persisting (\> 2 weeks) severe cytopenia due to any cause
- Patients with any known predisposition to bleeding
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib.
- Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.) Additional Exclusion Criteria For Sub-Study 4 Part A:
- Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen
- Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers/inhibitors.
- Previous treatment with rilvegostomig for the cohort treated with rilvegostomig
- Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9574
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Santa Monica, California, United States
- Santa Rosa, California, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- Commack, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Clayton, Australia
- Melbourne, Australia
- Nedlands, Australia
- Anderlecht, Belgium
- Leuven, Belgium
- Calgary, Alberta, Canada
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Santa Monica, California, United States; Santa Rosa, California, United States; Shreveport, Louisiana, United States; Baltimore, Maryland, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.