Actively Recruiting
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2025-11-21
862
Participants Needed
107
Research Sites
245 weeks
Total Duration
On this page
Sponsors
D
DualityBio Inc.
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
CONDITIONS
Official Title
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor relapsed or progressed after standard treatments or intolerable to them, or no standard treatment available
- At least one measurable tumor lesion per RECIST 1.1 or RANO 2.0 for GBM
- Life expectancy of 3 months or more
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher within 28 days before enrollment
- Adequate organ function within 7 days before starting treatment
- Adequate washout period from prior treatments before starting treatment
- Willing to provide tumor samples for biomarker analysis if possible
- Able to understand study procedures, provide written informed consent, and comply with study requirements
- Agree to use effective contraception during the study and for several months after treatment if of reproductive potential
- Male participants agree not to freeze or donate sperm during and for 4 months after the study
- Female participants agree not to donate or retrieve ova during and for 7 months after the study
- Specific criteria for various cancer types in Phase 2a cohorts as detailed (e.g., prior treatments, disease status)
- Additional inclusion criteria for drug interaction sub-study include expected treatment duration and ability to withhold certain medications
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy or certain antibody drug conjugates
- History of symptomatic congestive heart failure (NYHA class II-IV) or serious cardiac arrhythmia requiring treatment
- Recent myocardial infarction or unstable angina within 6 months before enrollment
- QT interval prolongation above specified thresholds or use of QT-prolonging medications without close monitoring
- History or current interstitial lung diseases or significant pulmonary disorders
- Significant gastrointestinal disorders affecting nutrition or with recent obstruction/perforation
- Untreated or high-risk esophageal or gastric varices with recent bleeding (for HCC patients)
- Metastatic disease involving major airways or blood vessels
- Uncontrolled fluid build-up requiring drainage or therapy within 2 weeks before enrollment
- Autoimmune or inflammatory disorders with pulmonary involvement
- Uncontrolled infection needing intravenous antibiotics, antivirals, or antifungals
- Known HIV infection
- Active viral hepatitis excluding certain controlled cases
- Pregnant or lactating women
- Spinal cord compression or active brain metastases requiring treatment
- Unresolved toxicities from prior cancer therapy above specified grades
- Multiple primary cancers within 3 years except certain adequately treated cases
- Substance abuse or medical conditions increasing safety risk or interfering with study
- Known allergies to study drugs or their ingredients
- Other reasons deemed unsuitable by investigator
- Contraindications to lopinavir, ritonavir, or itraconazole for drug interaction cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Research Site 111
Tucson, Arizona, United States, 85711
Actively Recruiting
2
Research Site 125
Los Angeles, California, United States, 90033
Actively Recruiting
3
Research Site 133
Los Angeles, California, United States, 90067
Actively Recruiting
4
Research Site 103
Los Angeles, California, United States, 90095
Actively Recruiting
5
Research Site 128
Santa Monica, California, United States, 90403
Actively Recruiting
6
Research Site 118
Celebration, Florida, United States, 34747
Actively Recruiting
7
Research Site 127
Margate, Florida, United States, 33063
Actively Recruiting
8
Research Site 137
Orlando, Florida, United States, 32827
Actively Recruiting
9
Research Site 101
Plantation, Florida, United States, 33322
Actively Recruiting
10
Research Site 109
Tamarac, Florida, United States, 33321
Actively Recruiting
11
Research Site 114
Atlanta, Georgia, United States, 30318
Actively Recruiting
12
Research Site 139
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Research Site 115
Louisville, Kentucky, United States, 40202
Actively Recruiting
14
Research Site 129
Detroit, Michigan, United States, 48201
Actively Recruiting
15
Research Site 121
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
16
Research Site 110
Las Vegas, Nevada, United States, 89169
Actively Recruiting
17
Research Site 107
New York, New York, United States, 10032
Actively Recruiting
18
Research Site 138
Canton, Ohio, United States, 44718
Actively Recruiting
19
Research Site 113
Cincinnati, Ohio, United States, 45267
Actively Recruiting
20
Research Site 131
Dayton, Ohio, United States, 45409
Actively Recruiting
21
Research Site 123
Charleston, South Carolina, United States, 29425
Actively Recruiting
22
Research Site 108
Greenville, South Carolina, United States, 29607
Actively Recruiting
23
Research Site 136
Nashville, Tennessee, United States, 37203
Actively Recruiting
24
Research Site 135
Austin, Texas, United States, 78731
Actively Recruiting
25
Research Site 120
Dallas, Texas, United States, 75390
Actively Recruiting
26
Research Site 102
Fairfax, Virginia, United States, 22031
Actively Recruiting
27
Research Site 112
Fairfax, Virginia, United States, 22031
Actively Recruiting
28
Research Site 105
Spokane, Washington, United States, 99208
Actively Recruiting
29
Research Site 208
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
30
Research Site 215
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
31
Research Site 212
Concord, New South Wales, Australia, 2139
Actively Recruiting
32
Research Site 217
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
33
Research Site 201
Sydney, New South Wales, Australia, 2031
Actively Recruiting
34
Research Site 205
Sydney, New South Wales, Australia, 2109
Actively Recruiting
35
Research Site 206
Sydney, New South Wales, Australia, 2228
Actively Recruiting
36
Research Site 216
Waratah, New South Wales, Australia, 2298
Actively Recruiting
37
Research Site 209
Birtinya, Queensland, Australia, 4575
Actively Recruiting
38
Research Site 203
Brisbane, Queensland, Australia, 4102
Actively Recruiting
39
Research Site 210
Gold Coast, Queensland, Australia, 4224
Actively Recruiting
40
Research Site 202
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
41
Research Site 207
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
42
Research Site 319
Hefei, Anhui, China, 230031
Actively Recruiting
43
Research Site 365
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
44
Research Site 310
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
45
Research Site 337
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
46
Research Site 327
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
47
Research Site 345
Chongqing, Chongqing Municipality, China, 400072
Actively Recruiting
48
Research Site 353
Chongqing, Chongqing Municipality, China, 400072
Actively Recruiting
49
Research Site 356
Chongqing, Chongqing Municipality, China, 400072
Actively Recruiting
50
Research Site 313
Fuzhou, Fujian, China, 350001
Actively Recruiting
51
Research Site 314
Guangzhou, Guangdong, China, 510060
Actively Recruiting
52
Research Site 322
Guangzhou, Guangdong, China, 510060
Actively Recruiting
53
Research site 367
Guangzhou, Guangdong, China, 510120
Actively Recruiting
54
Research Site 346
Guangzhou, Guangdong, China, 510282
Actively Recruiting
55
Research Site 348
Guangzhou, Guangdong, China, 510300
Actively Recruiting
56
Research Site 350
Guangzhou, Guangdong, China, 510515
Actively Recruiting
57
Research Site 360
Nanning, Guangxi, China, 530021
Actively Recruiting
58
Research Site 334
Baoding, Hebei, China, 071030
Actively Recruiting
59
Research Site 315
Harbin, Heilongjiang, China, 150081
Actively Recruiting
60
Research Site 316
Luoyang, Henan, China, 450000
Actively Recruiting
61
Research Site 317
Xinxiang, Henan, China, 453100
Actively Recruiting
62
Research Site 306
Zhengzhou, Henan, China, 450000
Actively Recruiting
63
Research Site 304
Zhengzhou, Henan, China, 450052
Actively Recruiting
64
Research Site 321
Wuhan, Hubei, China, 430000
Actively Recruiting
65
Research Site 311
Wuhan, Hubei, China, 430030
Actively Recruiting
66
Research Site 309
Changsha, Hunan, China, 410031
Actively Recruiting
67
Research Site 323
Changsha, Hunan, China, 410031
Actively Recruiting
68
Research Site 344
Nanjing, Jiangsu, China, 210008
Actively Recruiting
69
Research Site 305
Nanjing, Jiangsu, China, 21000
Actively Recruiting
70
Research Site 307
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
71
Research Site 349
Nanchang, Jiangxi, China, 330006
Actively Recruiting
72
Research Site 361
Nanchang, Jiangxi, China, 330029
Actively Recruiting
73
Research Site 328
Changchun, Jilin, China, 130000
Actively Recruiting
74
Research Site 301
Changchun, Jilin, China, 130012
Actively Recruiting
75
Research Site 320
Shenyang, Liaoning, China, 110000
Actively Recruiting
76
Research Site 352
Shenyang, Liaoning, China, 110042
Actively Recruiting
77
Research Site 363
Nanjing, Nanjing, China, 210006
Actively Recruiting
78
Research Site 340
Jinan, Shandong, China, 250013
Actively Recruiting
79
Research Site 308
Jinan, Shandong, China, 250117
Actively Recruiting
80
Research Site 333
Linyi, Shandong, China, 276000
Actively Recruiting
81
Research Site 302
Linyi, Shandong, China, 276034
Actively Recruiting
82
Research Site 335
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
83
Research Site 326
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
84
Research Site 355
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
85
Research Site 332
Xi’an, Shanxi, China, 710000
Actively Recruiting
86
Research Site 312
Chengdu, Sichuan, China, 610041
Actively Recruiting
87
Research Site 330
Chengdu, Sichuan, China, 610041
Actively Recruiting
88
Research Site 366
Chengdu, Sichuan, China, 610041
Actively Recruiting
89
Research Site 325
Chengdu, Sichuan, China, 610072
Actively Recruiting
90
Research Site 347
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
91
Research Site 318
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
92
Research site 368
Tianjin, Tianjin Municipality, China, 300300
Actively Recruiting
93
Research Site 324
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
94
Research Site 329
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
95
Research Site 331
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
96
Research Site 359
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
97
Research site 369
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
98
Research Site 303
Taizhou, Zhejiang, China, 317099
Actively Recruiting
99
Research Site 408
Kaohsiung City, Taiwan, 807377
Actively Recruiting
100
Research Site 405
Kaohsiung City, Taiwan, 824005
Actively Recruiting
101
Research Site 406
New Taipei City, Taiwan, 235041
Actively Recruiting
102
Research Site 401
Taipei, Taiwan, 100225
Actively Recruiting
103
Research Site 402
Taipei, Taiwan, 100225
Actively Recruiting
104
Research Site 409
Taipei, Taiwan, 104217
Actively Recruiting
105
Research Site 403
Taipei, Taiwan, 110301
Actively Recruiting
106
Research Site 407
Taipei, Taiwan, 112201
Actively Recruiting
107
Research Site 404
Taoyuan, Taiwan, 333423
Actively Recruiting
Research Team
L
Ling Li
CONTACT
T
Tiana Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
23
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here