Actively Recruiting
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
Led by AstraZeneca · Updated on 2026-03-02
506
Participants Needed
60
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors
CONDITIONS
Official Title
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Provide signed consent for optional genetic research or agree to participate without it
- Age 18 years or older at time of consent
- Willing to provide adequate archival or baseline tumor samples as needed
- Fresh biopsy required if prior targeted therapies received unless recent tissue sample collected after treatment
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Have advanced solid tumors with prior adequate therapy per local practice or clinical trial considered best next step
- Have measurable disease by RECIST v1.1 criteria
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function
- Use contraception consistent with local regulations for men and women during and after study treatment
- Female participants of childbearing potential must have negative pregnancy tests before treatment and each cycle
You will not qualify if you...
- Spinal cord compression or history of leptomeningeal carcinomatosis
- Brain metastases unless asymptomatic, stable, and not requiring corticosteroids >10 mg prednisone/day for at least 4 weeks
- Recent treatment with prohibited medications without required washout
- Unresolved toxicities grade 2 or higher from prior therapy except certain controlled conditions
- Active infections including uncontrolled HIV, HBV, or HCV
- Interstitial lung disease or pneumonitis requiring steroids or oxygen, or suspected but not ruled out
- Other malignancies within prior 2 years except certain treated localized cancers
- Significant cardiac conditions including symptomatic arrhythmias, uncontrolled hypertension, recent heart attack or stroke, symptomatic heart failure, or certain QT prolongation risks
- Uncontrolled illnesses or conditions limiting study compliance or increasing risk
- Substance abuse or other medical conditions interfering with participation
- Receipt of live vaccines within 30 days before first dose
- Pregnant or breastfeeding women or those intending pregnancy during study
- Concurrent enrollment in other interventional clinical studies
- Known hypersensitivity to study drugs or excipients
- Involvement in study planning or conduct
- Inability to comply with study procedures or previous enrollment in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 60 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
Irvine, California, United States, 92618
Actively Recruiting
3
Research Site
La Jolla, California, United States, 92093
Withdrawn
4
Research Site
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Research Site
Louisville, Kentucky, United States, 40202
Terminated
6
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Research Site
Columbus, Ohio, United States, 43201
Actively Recruiting
9
Research Site
Portland, Oregon, United States, 97239
Actively Recruiting
10
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
11
Research Site
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
13
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
14
Research Site
Liverpool, Australia, 2170
Actively Recruiting
15
Research Site
Melbourne, Australia, 3000
Actively Recruiting
16
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
17
Research Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
18
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
19
Research Site
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
20
Research Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
21
Research Site
Chengdu, China, 610041
Actively Recruiting
22
Research Site
Chongqing, China, 400030
Actively Recruiting
23
Research Site
Guangzhou, China, 510000
Actively Recruiting
24
Research Site
Guangzhou, China, 510060
Actively Recruiting
25
Research Site
Jinan, China, 250117
Actively Recruiting
26
Research Site
Xi'an, China, 710061
Actively Recruiting
27
Research Site
Zhengzhou, China, 450008
Actively Recruiting
28
Research Site
Berlin, Germany, 13353
Not Yet Recruiting
29
Research Site
Essen, Germany, 45136
Not Yet Recruiting
30
Research Site
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
31
Research Site
Hanover, Germany, 30625
Actively Recruiting
32
Research Site
Leipzig, Germany, 04103
Actively Recruiting
33
Research Site
Mannheim, Germany, 68167
Actively Recruiting
34
Research Site
Regensburg, Germany, 93053
Actively Recruiting
35
Research Site
Haifa, Israel, 3109601
Actively Recruiting
36
Research Site
Ramat Gan, Israel, 52621
Actively Recruiting
37
Research Site
Hidaka-shi, Japan, 350-1298
Actively Recruiting
38
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
39
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
40
Research Site
Sunto-gun, Japan, 411-8777
Actively Recruiting
41
Research Site
Tokyo, Japan, 104-0045
Actively Recruiting
42
Research Site
Seoul, South Korea, 03080
Actively Recruiting
43
Research Site
Seoul, South Korea, 06351
Actively Recruiting
44
Research Site
Barcelona, Spain, 8035
Actively Recruiting
45
Research Site
Madrid, Spain, 28041
Actively Recruiting
46
Research Site
Madrid, Spain, 28050
Actively Recruiting
47
Research Site
Málaga, Spain, 29010
Actively Recruiting
48
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
49
Research Site
Tainan, Taiwan, 70403
Actively Recruiting
50
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
51
Research Site
Taipei, Taiwan, 11259
Actively Recruiting
52
Research Site
Ankara, Turkey (Türkiye), 06050
Actively Recruiting
53
Research Site
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
54
Research Site
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
55
Research Site
Istanbul, Turkey (Türkiye), 34718
Actively Recruiting
56
Research Site
Cambridge, United Kingdom, CB2 0XY
Actively Recruiting
57
Research Site
Glasgow, Scotland, United Kingdom, G12 0YN
Actively Recruiting
58
Research Site
London, United Kingdom, SE1 9RT
Not Yet Recruiting
59
Research Site
London, United Kingdom, SW3 6JJ
Actively Recruiting
60
Research Site
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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