A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a new drug, AZD8205, alone or with other cancer drugs. It is for adults with solid tumors that have grown nearby or spread to other parts of the body.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be at least 18 years old.
- Your cancer has come back or spread. You have had standard treatment, or the study doctor thinks a trial is your best next treatment.
- Your cancer must be measurable on scans.
- You must be fully active or able to walk and do light work. You must be expected to live at least 12 weeks.
- Your bone marrow, which makes blood cells, liver, and kidneys must work well enough.
- Your study group must match your cancer type, confirmed by tissue or cell tests. Groups include breast, ovarian, bile duct, endometrial (womb lining), and squamous non-small cell lung cancer. Not all groups accept every type.
- You must weigh at least 30 kg (about 66 pounds) for Sub-Study 2 Part A, and for groups using rilvegostomig in Sub-Studies 3 and 4.
- For Sub-Study 4 Part A, cancer must have worsened after 1 to 3 courses of treatment for cancer that spread or came back. The study doctor must find no suitable other treatment.
Who can't join
- You had cancer treatment or an experimental drug too recently. Required waiting times depend on the drug and can be up to 6 weeks.
- You have pressure on the spinal cord or a history of cancer in the lining around the brain or spinal cord. Cancer in the brain is allowed only if treated, stable, and causing no symptoms, with no need for more than 10 mg of prednisone daily or an equal steroid dose for at least 4 weeks.
- You have an active infection, including tuberculosis, hepatitis B or C, or HIV.
- You have current or suspected lung inflammation, past lung inflammation not caused by infection that needed steroids, or severe breathing problems from other lung illness.
- You have certain serious heart problems, abnormal heart rhythms, uncontrolled high blood pressure, or problems with blood flow to the brain. Some recent heart events, heart procedures, strokes, or mini-strokes also rule you out.
- You have had, or tests suggest, myelodysplastic syndrome or acute myeloid leukemia—diseases of the blood-forming cells.
- For Sub-Study 2 Part A: prior immune-based cancer treatment caused side effects that made you stop it for good; you have an immune or inflammatory illness needing long-term immune-suppressing drugs; or you have had an organ transplant. Prior TOP1 inhibitor cancer drugs also rule you out of Sub-Study 2 Part B and Sub-Studies 3 and 4 Part A.
- For Sub-Studies 3 and 4 Part A: certain drugs or herbs that affect drug breakdown, or problems swallowing or absorbing the study pills, rule you out. Sub-Study 3 also excludes severe low blood cell counts lasting over 2 weeks or a tendency to bleed. Sub-Study 4 also excludes prior AZD9574, more than one prior course of PARP inhibitor treatment, or prior rilvegostomig if joining its treatment group.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 bone marrow, hepatic, and renal function as defined in the protocol Additional Inclusion Criteria For Sub-Study 1 Part A: • Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer Additional Inclusion Criteria 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) 5. Cohort B5 (Squamous Non-Small Cell Lung Cancer) Additional Inclusion Criteria 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 Inclusion Criteria 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 Inclusion Criteria 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 Investigator. Key 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. * 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 Part A: * 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
Study sites (14)
CA
- Research Site · Duarte, CA 91010More trials in Duarte
- Research Site · Irvine, CA 92618More trials in Irvine
- Research Site · Santa Monica, CA 90404More trials in Santa Monica
- Research Site · Santa Rosa, CA 95403More trials in Santa Rosa
LA
- Research Site · Shreveport, LA 71103More trials in Shreveport
MA
- Research Site · Boston, MA 02215More trials in Boston
MD
- Research Site · Baltimore, MD 21231More trials in Baltimore
MO
- Research Site · St Louis, MO 63110More trials in St Louis
NC
- Research Site · Charlotte, NC 28204More trials in Charlotte
NM
- Research Site · Albuquerque, NM 87109More trials in Albuquerque
NY
- Research Site · Commack, NY 11725More trials in Commack
- Research Site · New York, NY 10029More trials in New York
PA
- Research Site · Pittsburgh, PA 15213More trials in Pittsburgh
TX
- Research Site · Houston, TX 77030More trials in Houston