Actively Recruiting
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
Led by AstraZeneca · Updated on 2026-03-23
460
Participants Needed
67
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Relapsed or metastatic solid tumors treated with prior standard therapy or where clinical trial is best next treatment
- Measurable disease per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and kidney function as defined in the protocol
- Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast, ovarian, biliary tract, or endometrial cancer for Sub-Study 1 Part A
- Confirmed metastatic or locally advanced/recurrent disease for cohorts in Sub-Study 1 Part B: biliary tract, ovarian, breast, endometrial, or squamous non-small cell lung cancer
- Minimum body weight 30 kg for Sub-Studies 2 Part A, 3 Part A, and 4 Part A (with rilvegostomig cohorts)
- Progression after 1 to 3 prior treatment lines for metastatic or relapsed disease with no satisfactory alternative treatment for Sub-Study 4 Part A
You will not qualify if you...
- Treatment with nitrosourea or mitomycin C within 6 weeks before first study dose
- Use of investigational agents or prior study drugs within 5 half-lives or 28 days before first study dose
- Other anticancer treatments within specified washout periods: 21 days for cytotoxic and non-cytotoxic drugs, 28 days for biological products
- Spinal cord compression or history of leptomeningeal carcinomatosis
- Untreated or unstable brain metastases requiring corticosteroids above 10 mg prednisone daily
- Active infections including tuberculosis, hepatitis B or C, or HIV
- History or presence of interstitial lung disease/pneumonitis requiring steroids or suspected but not ruled out by imaging
- Severe pulmonary compromise due to other illnesses
- Significant cardiac conditions including symptomatic arrhythmia, uncontrolled hypertension, recent heart events, heart failure, cardiomyopathy, severe valve disease, prolonged QTc interval, or risk factors for arrhythmias
- History of myelodysplastic syndrome or acute myeloid leukemia
- Prior thromboembolic event within 3 months (no longer applicable)
- Permanent discontinuation of prior immunotherapy due to toxicity
- Active or prior autoimmune or inflammatory disorders needing chronic immunosuppressive treatment
- History of organ transplant
- Previous treatment with TOP1 inhibitors
- Use of medications affecting cytochrome P450 3A4 strongly
- Severe or prolonged cytopenia, bleeding risk, severe gastrointestinal conditions affecting drug absorption
- Prior treatment with AZD9574 or more than one prior PARP inhibitor regimen
- Previous treatment with rilvegostomig for rilvegostomig cohorts
- Refractory nausea, vomiting, or bowel conditions impairing drug absorption for relevant cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Active, Not Recruiting
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
Not Yet 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
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
A
AstraZeneca Breast Cancer Study Locator Service
CONTACT
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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