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NCT05123482 | RECRUITING | Breast Cancer

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

AstraZeneca

Brief Summary:

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

Condition or disease

Breast Cancer

Biliary Tract Carcinoma

Ovarian Cancer

Endometrial Cancer

Squamous Non-Small Cell Lung Cancer

Intervention/treatment

AZD8205

AZD8205 and AZD2936 (Rilvegostomig)

AZD8205 and AZD5305 (saruparib)

AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)

Phase

PHASE1

PHASE2

Detailed Description:

This study is 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 370 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2021-10-18
Estimated Primary Completion Date : 2027-03-26
Estimated Study Completion Date : 2027-03-26

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
          • 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.
                  • 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 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
                      • * Patients with history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation).
                      • * 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.
A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies

Location Details

NCT05123482

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Research Site

Duarte, California, United States, 91010

RECRUITING

United States, California

Research Site

Irvine, California, United States, 92618

RECRUITING

United States, California

Research Site

Santa Monica, California, United States, 90404

RECRUITING

United States, California

Research Site

Santa Rosa, California, United States, 95403

WITHDRAWN

United States, Florida

Research Site

Sarasota, Florida, United States, 34232

RECRUITING

United States, Louisiana

Research Site

Shreveport, Louisiana, United States, 71103

RECRUITING

United States, Maryland

Research Site

Baltimore, Maryland, United States, 21231

RECRUITING

United States, Massachusetts

Research Site

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Missouri

Research Site

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New Mexico

Research Site

Albuquerque, New Mexico, United States, 87109

RECRUITING

United States, New York

Research Site

Commack, New York, United States, 11725

WITHDRAWN

United States, New York

Research Site

New York, New York, United States, 10029

RECRUITING

United States, North Carolina

Research Site

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, Pennsylvania

Research Site

Pittsburgh, Pennsylvania, United States, 15213

RECRUITING

United States, Texas

Research Site

Houston, Texas, United States, 77030

RECRUITING

Australia,

Research Site

Clayton, Australia, 3168

RECRUITING

Australia,

Research Site

Melbourne, Australia, VIC 3000

RECRUITING

Australia,

Research Site

Nedlands, Australia, 6009

WITHDRAWN

Australia,

Research Site

South Brisbane, Australia, 4101

RECRUITING

Belgium,

Research Site

Anderlecht, Belgium, 1070

RECRUITING

Belgium,

Research Site

Leuven, Belgium, 3000

RECRUITING

Canada, Alberta

Research Site

Calgary, Alberta, Canada, T2N 5G2

RECRUITING

Canada, British Columbia

Research Site

Vancouver, British Columbia, Canada, V5Z 4E6

RECRUITING

Canada, Ontario

Research Site

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

Research Site

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

Research Site

Montreal, Quebec, Canada, H4A 3J1

RECRUITING

China,

Research Site

Beijing, China, 100142

RECRUITING

China,

Research Site

Changsha, China, 410013

RECRUITING

China,

Research Site

Chongqing, China, 400030

RECRUITING

China,

Research Site

Guangzhou, China, 510060

NOT YET RECRUITING

China,

Research Site

Kunming, China, 650118

NOT YET RECRUITING

China,

Research Site

Shandong, China,

WITHDRAWN

Hungary,

Research Site

Budapest, Hungary, 1062

RECRUITING

Hungary,

Research Site

Budapest, Hungary, 1082

RECRUITING

Hungary,

Research Site

Budapest, Hungary, 1122

RECRUITING

Italy,

Research Site

Milan, Italy, 20141

RECRUITING

Italy,

Research Site

Modena, Italy, 41125

RECRUITING

Italy,

Research Site

Roma, Italy, 00168

RECRUITING

Italy,

Research Site

Rozzano, Italy, 20089

RECRUITING

Japan,

Research Site

C-Cry, Japan, 104-0045

RECRUITING

Japan,

Research Site

Mr. Hidaka, Japan, 350-1298

RECRUITING

Japan,

Research Site

Kashiwa, Japan, 277-8577

RECRUITING

Japan,

Research Site

Small talk, Japan, 135-8550

RECRUITING

Japan,

Research Site

Mr. Kurume, Japan, 830-0011

RECRUITING

Japan,

Research Site

Summary-gun, Japan, 411-8777

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03080

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 05505

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 06351

RECRUITING

Netherlands,

Research Site

Amsterdam, Netherlands, 1066 CX

RECRUITING

Poland,

Research Site

Gdańsk, Poland, 80-214

RECRUITING

Poland,

Research Site

Warsaw, Poland, 02-781

RECRUITING

Spain,

Research Site

Barcelona, Spain, 8035

RECRUITING

Spain,

Research Site

L'Hospitalet de Llobregat, Spain, 08908

RECRUITING

Spain,

Research Site

Madrid, Spain, 28027

RECRUITING

Spain,

Research Site

Málaga, Spain, 29010

RECRUITING

Spain,

Research Site

Pamplona, Spain, 31008

RECRUITING

Taiwan,

Research Site

Tainan, Taiwan, 704

RECRUITING

Taiwan,

Research Site

Taipei, Taiwan, 10002

RECRUITING

Taiwan,

Research Site

Taipei, Taiwan, 11259

RECRUITING

Taiwan,

Research Site

taoyuan, Taiwan, 333

RECRUITING

Thailand,

Research Site

Bangkok, Thailand, 10330

RECRUITING

Thailand,

Research Site

Chiang Mai, Thailand, 50200

RECRUITING

United Kingdom,

Research Site

Cambridge, United Kingdom, CB2 0XY

RECRUITING

United Kingdom,

Research Site

Cardiff, United Kingdom, CF14 2TL

RECRUITING

United Kingdom,

Research Site

London, United Kingdom, Ec1a 7be