Extensive Biotransformation Profiling of AZD8205, an Anti-B7-H4 Antibody-Drug Conjugate, Elucidates Pathways Underlying Its Stability In Vivo.
Yue Huang, Hui Yin Tan, Jiaqi Yuan...
https://pubmed.ncbi.nlm.nih.gov/39392424Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05123482
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)
Led by AstraZeneca · Updated on 2026-05-18
460
Participants Needed
67
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD8205, a new antibody drug conjugate, as a possible treatment for advanced or metastatic solid tumors including breast cancer, biliary tract cancer, ovarian cancer, endometrial cancer, and squamous non-small cell lung cancer. This Phase I/IIa multi-center, open-label study aims to determine the safety, tolerability, and effectiveness of AZD8205 alone or combined with other anticancer agents such as rilvegostomig, saruparib, and AZD9574 in participants with advanced solid tumors. The study consists of four sub-studies, each with dose escalation and expansion phases. Sub-Study 1 tests AZD8205 alone; Sub-Study 2 evaluates AZD8205 combined with rilvegostomig; Sub-Study 3 assesses AZD8205 combined with saruparib, with possible addition of rilvegostomig; and Sub-Study 4 examines AZD8205 combined with AZD9574, with possible addition of rilvegostomig. Participants receive the study drugs according to assigned groups, and doses are adjusted to find the recommended dose and assess anti-tumor activity. Participants undergo regular assessments including monitoring for adverse events, laboratory tests, ECGs, and vital signs from consent through 30 days after the last dose, lasting about one year. Tumor response, survival, pharmacokinetics, and immunogenicity are evaluated over approximately two years. Safety and tolerability are closely tracked throughout. The study involves randomized allocation without blinding, with detailed follow-up to measure the impact of the treatments on disease progression and patient health.
CONDITIONS
Brief Title
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Relapsed or metastatic solid tumors treated with prior adequate standard therapy or where a clinical trial is the best next treatment
- Measurable disease per RECIST v1.1
- ECOG Performance Status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and kidney function
- For Sub-Study 1 Part A: confirmed metastatic or locally advanced/recurrent breast, ovarian, biliary tract, or endometrial cancer
- For Sub-Study 1 Part B: confirmed metastatic or locally advanced/recurrent disease in select cohorts including biliary tract, ovarian, breast, endometrial, and squamous non-small cell lung cancer
- For Sub-Studies 2 and 3 Part A: minimum body weight 30 kg and confirmed metastatic or locally advanced/recurrent breast, ovarian, biliary tract, endometrial, or squamous non-small cell lung cancer
- For Sub-Study 4 Part A: minimum body weight 30 kg, confirmed metastatic or locally advanced/recurrent breast, endometrial, or squamous non-small cell lung cancer, progressed after 1 to 3 prior treatments with no satisfactory alternatives
You will not qualify if you...
- Treatment with nitrosourea or mitomycin C within 6 weeks before first study dose
- Use of investigational agents within 5 half-lives or 28 days before first dose
- Other anticancer treatments within specified timeframes before first dose: cytotoxic (21 days), non-cytotoxic (21 days or 5 half-lives), biological including immuno-oncology (28 days)
- Spinal cord compression or leptomeningeal carcinomatosis history
- Untreated or symptomatic brain metastases requiring steroids above 10 mg prednisone daily
- Active infections including tuberculosis, hepatitis B, hepatitis C, or HIV
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected on imaging
- Severe pulmonary illness
- Specific cardiac conditions including symptomatic arrhythmias, uncontrolled hypertension, recent acute coronary events, stroke or TIA within 6 months, symptomatic heart failure NYHA class 2 or above, cardiomyopathy, severe valvular disease, prolonged QTcF >470 msec, or risk factors for arrhythmia
- History of myelodysplastic syndrome or acute myeloid leukemia
- Additional criteria for Sub-Study 2: recent thromboembolic events, prior immunotherapy toxicity, autoimmune disorders needing immunosuppressants, organ transplant history, prior TOP1i treatment
- Additional criteria for Sub-Study 3: strong CYP3A4 inducer/inhibitor use, severe cytopenia, bleeding predisposition, gastrointestinal issues affecting drug absorption, prior TOP1i treatment
- Additional criteria for Sub-Study 4: prior AZD9574 or multiple PARPi regimens, CYP3A4 inducer/inhibitor use, previous rilvegostomig or TOP1i treatment, gastrointestinal conditions affecting absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 2 years or until disease progression or unacceptable toxicity
Participants receive AZD8205 alone or in combination with other anticancer agents to treat advanced or metastatic solid tumors. Treatment is given in sequential dose escalation and expansion sub-studies to evaluate safety, tolerability, and anti-tumor activity.
Regular visits throughout treatment duration for dosing and assessments
Follow-up
Duration - Approximately 1 month after last dose
Participants are monitored for safety and survival for up to 30 days after their last dose of treatment.
1 to 2 visits post-treatment
Trial Site Locations
Total: 67 locations
1
Research Site
Duarte, California, United States, 91010
Completed
2
Research Site
Irvine, California, United States, 92618
Completed
3
Research Site
Santa Monica, California, United States, 90404
Actively Recruiting
4
Research Site
Santa Rosa, California, United States, 95403
Actively Recruiting
5
Research Site
Shreveport, Louisiana, United States, 71103
Completed
6
Research Site
Baltimore, Maryland, United States, 21231
Actively Recruiting
7
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Research Site
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
10
Research Site
Commack, New York, United States, 11725
Actively Recruiting
11
Research Site
New York, New York, United States, 10029
Withdrawn
12
Research Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
13
Research Site
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
15
Research Site
Clayton, Australia, 3168
Terminated
16
Research Site
Melbourne, Australia, VIC 3000
Actively Recruiting
17
Research Site
Nedlands, Australia, 6009
Actively Recruiting
18
Research Site
Anderlecht, Belgium, 1070
Actively Recruiting
19
Research Site
Leuven, Belgium, 3000
Actively Recruiting
20
Research Site
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
21
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
22
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
23
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
24
Research Site
Montreal, Quebec, Canada, H4A 3J1
Completed
25
Research Site
Beijing, China, 100142
Completed
26
Research Site
Beijing, China, 100142
Actively Recruiting
27
Research Site
Changsha, China, 410013
Terminated
28
Research Site
Changsha, China, 410013
Actively Recruiting
29
Research Site
Chongqing, China, 400030
Actively Recruiting
30
Research Site
Guangzhou, China, 510060
Completed
31
Research Site
Kunming, China, 650118
Actively Recruiting
32
Research Site
Shandong, China
Actively Recruiting
33
Research Site
Budapest, Hungary, 1062
Withdrawn
34
Research Site
Budapest, Hungary, 1082
Actively Recruiting
35
Research Site
Budapest, Hungary, 1122
Actively Recruiting
36
Research Site
Milan, Italy, 20141
Actively Recruiting
37
Research Site
Modena, Italy, 41125
Actively Recruiting
38
Research Site
Roma, Italy, 00168
Actively Recruiting
39
Research Site
Rozzano, Italy, 20089
Actively Recruiting
40
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
41
Research Site
Hidaka-shi, Japan, 350-1298
Actively Recruiting
42
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
43
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
44
Research Site
Kurume-shi, Japan, 830-0011
Actively Recruiting
45
Research Site
Sunto-gun, Japan, 411-8777
Actively Recruiting
46
Research Site
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
47
Research Site
Gdansk, Poland, 80-214
Actively Recruiting
48
Research Site
Warsaw, Poland, 02-781
Actively Recruiting
49
Research Site
Seoul, South Korea, 03080
Actively Recruiting
50
Research Site
Seoul, South Korea, 03722
Actively Recruiting
51
Research Site
Seoul, South Korea, 05505
Actively Recruiting
52
Research Site
Seoul, South Korea, 06351
Actively Recruiting
53
Research Site
Barcelona, Spain, 8035
Actively Recruiting
54
Research Site
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
55
Research Site
Madrid, Spain, 28027
Actively Recruiting
56
Research Site
Málaga, Spain, 29010
Actively Recruiting
57
Research Site
Pamplona, Spain, 31008
Actively Recruiting
58
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
59
Research Site
Tainan, Taiwan, 704
Actively Recruiting
60
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
61
Research Site
Taipei, Taiwan, 11259
Actively Recruiting
62
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
63
Research Site
Bangkok, Thailand, 10330
Actively Recruiting
64
Research Site
Chiang Mai, Thailand, 50200
Actively Recruiting
65
Research Site
Cambridge, United Kingdom, CB2 0XY
Actively Recruiting
66
Research Site
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
67
Research Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
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Research Team
A
AstraZeneca Clinical Study Information Center
A
AstraZeneca Breast Cancer Study Locator Service
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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