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A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2025-11-21
862
Participants Needed
107
Research Sites
21 weeks
Total Duration
On this page
Sponsors
D
DualityBio Inc.
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying DB-1311/BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 1/2a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311/BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Participants receive intravenous doses of DB-1311/BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311/BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drug’s safety and preliminary antitumor activity. Participants' health and cancer are closely followed throughout and after treatment.
CONDITIONS
Brief 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
- Confirmed advanced or metastatic solid tumor that has relapsed or progressed after standard treatments or has no standard treatment available
- At least one measurable tumor lesion as per RECIST 1.1 or RANO 2.0 criteria for brain tumors
- Life expectancy of 3 months or more
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Adequate organ function and treatment washout prior to starting study treatment
- Willingness to provide tumor samples for biomarker testing if possible
- Ability to understand and provide informed consent
- Agreement to use effective contraception during and after the study as applicable
- Specific tumor type and prior treatment requirements for certain cohorts as detailed in the protocol
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy or topoisomerase inhibitor antibody drug conjugates
- History of symptomatic congestive heart failure or serious cardiac arrhythmia needing treatment
- Recent myocardial infarction or unstable angina within 6 months
- Prolonged QT interval or use of medications that prolong QT interval without close monitoring
- Current or history of interstitial lung disease or significant pulmonary disorders
- Severe gastrointestinal disorders or recent bleeding from esophageal/gastric varices (for liver cancer patients)
- Metastatic disease involving major airways or blood vessels
- Uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage
- Autoimmune or inflammatory disorders with suspected lung involvement
- Uncontrolled infections needing intravenous antibiotics or antivirals
- Known HIV infection
- Active viral hepatitis, except controlled chronic hepatitis B or cured hepatitis C
- Pregnant or breastfeeding women
- Untreated or symptomatic brain metastases requiring steroids or anticonvulsants
- Unresolved toxicities from prior cancer treatments above grade 1, except alopecia
- Multiple primary cancers within 3 years except certain treated skin or in-situ cancers
- Substance abuse or medical conditions that increase risk or interfere with study
- Allergies to study drugs or their ingredients
- Contraindications to lopinavir, ritonavir, or itraconazole for participants in drug interaction cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive DB-1311/BNT324 as a single intravenous infusion once every 3 weeks in 21-day cycles. Some participants may receive DB-1311 alone or in combination with oral hormone therapies or drug interaction agents depending on their cohort.
1 visit every 3 weeks for infusion
Duration - Approximately 1 year post-treatment
Participants are monitored for safety, adverse events, and treatment response for approximately 1 year after treatment ends.
Periodic visits during follow-up period
Trial Site Locations
Total: 107 locations
1
Research Site 111
Tucson, Arizona, United States, 85711
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2
Research Site 125
Los Angeles, California, United States, 90033
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3
Research Site 133
Los Angeles, California, United States, 90067
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4
Research Site 103
Los Angeles, California, United States, 90095
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5
Research Site 128
Santa Monica, California, United States, 90403
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6
Research Site 118
Celebration, Florida, United States, 34747
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7
Research Site 127
Margate, Florida, United States, 33063
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8
Research Site 137
Orlando, Florida, United States, 32827
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9
Research Site 101
Plantation, Florida, United States, 33322
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10
Research Site 109
Tamarac, Florida, United States, 33321
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11
Research Site 114
Atlanta, Georgia, United States, 30318
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12
Research Site 139
Atlanta, Georgia, United States, 30322
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13
Research Site 115
Louisville, Kentucky, United States, 40202
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14
Research Site 129
Detroit, Michigan, United States, 48201
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15
Research Site 121
Saint Paul, Minnesota, United States, 55101
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16
Research Site 110
Las Vegas, Nevada, United States, 89169
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17
Research Site 107
New York, New York, United States, 10032
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18
Research Site 138
Canton, Ohio, United States, 44718
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19
Research Site 113
Cincinnati, Ohio, United States, 45267
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20
Research Site 131
Dayton, Ohio, United States, 45409
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21
Research Site 123
Charleston, South Carolina, United States, 29425
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22
Research Site 108
Greenville, South Carolina, United States, 29607
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23
Research Site 136
Nashville, Tennessee, United States, 37203
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24
Research Site 135
Austin, Texas, United States, 78731
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25
Research Site 120
Dallas, Texas, United States, 75390
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26
Research Site 102
Fairfax, Virginia, United States, 22031
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27
Research Site 112
Fairfax, Virginia, United States, 22031
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28
Research Site 105
Spokane, Washington, United States, 99208
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29
Research Site 208
Blacktown, New South Wales, Australia, 2148
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30
Research Site 215
Camperdown, New South Wales, Australia, 2050
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31
Research Site 212
Concord, New South Wales, Australia, 2139
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32
Research Site 217
New Lambton Heights, New South Wales, Australia, 2305
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33
Research Site 201
Sydney, New South Wales, Australia, 2031
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34
Research Site 205
Sydney, New South Wales, Australia, 2109
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35
Research Site 206
Sydney, New South Wales, Australia, 2228
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36
Research Site 216
Waratah, New South Wales, Australia, 2298
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37
Research Site 209
Birtinya, Queensland, Australia, 4575
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38
Research Site 203
Brisbane, Queensland, Australia, 4102
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39
Research Site 210
Gold Coast, Queensland, Australia, 4224
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40
Research Site 202
Nedlands, Western Australia, Australia, 6009
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41
Research Site 207
Nedlands, Western Australia, Australia, 6009
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42
Research Site 319
Hefei, Anhui, China, 230031
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43
Research Site 365
Beijing, Beijing Municipality, China, 100034
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44
Research Site 310
Beijing, Beijing Municipality, China, 100142
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45
Research Site 337
Beijing, Beijing Municipality, China, 100142
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46
Research Site 327
Chongqing, Chongqing Municipality, China, 400030
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47
Research Site 345
Chongqing, Chongqing Municipality, China, 400072
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48
Research Site 353
Chongqing, Chongqing Municipality, China, 400072
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49
Research Site 356
Chongqing, Chongqing Municipality, China, 400072
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50
Research Site 313
Fuzhou, Fujian, China, 350001
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51
Research Site 314
Guangzhou, Guangdong, China, 510060
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52
Research Site 322
Guangzhou, Guangdong, China, 510060
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53
Research site 367
Guangzhou, Guangdong, China, 510120
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54
Research Site 346
Guangzhou, Guangdong, China, 510282
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55
Research Site 348
Guangzhou, Guangdong, China, 510300
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56
Research Site 350
Guangzhou, Guangdong, China, 510515
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57
Research Site 360
Nanning, Guangxi, China, 530021
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58
Research Site 334
Baoding, Hebei, China, 071030
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59
Research Site 315
Harbin, Heilongjiang, China, 150081
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60
Research Site 316
Luoyang, Henan, China, 450000
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61
Research Site 317
Xinxiang, Henan, China, 453100
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62
Research Site 306
Zhengzhou, Henan, China, 450000
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63
Research Site 304
Zhengzhou, Henan, China, 450052
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64
Research Site 321
Wuhan, Hubei, China, 430000
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65
Research Site 311
Wuhan, Hubei, China, 430030
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66
Research Site 309
Changsha, Hunan, China, 410031
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67
Research Site 323
Changsha, Hunan, China, 410031
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68
Research Site 344
Nanjing, Jiangsu, China, 210008
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69
Research Site 305
Nanjing, Jiangsu, China, 21000
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70
Research Site 307
Ganzhou, Jiangxi, China, 341000
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71
Research Site 349
Nanchang, Jiangxi, China, 330006
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72
Research Site 361
Nanchang, Jiangxi, China, 330029
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73
Research Site 328
Changchun, Jilin, China, 130000
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74
Research Site 301
Changchun, Jilin, China, 130012
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75
Research Site 320
Shenyang, Liaoning, China, 110000
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76
Research Site 352
Shenyang, Liaoning, China, 110042
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77
Research Site 363
Nanjing, Nanjing, China, 210006
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78
Research Site 340
Jinan, Shandong, China, 250013
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79
Research Site 308
Jinan, Shandong, China, 250117
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80
Research Site 333
Linyi, Shandong, China, 276000
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81
Research Site 302
Linyi, Shandong, China, 276034
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82
Research Site 335
Shanghai, Shanghai Municipality, China, 200030
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83
Research Site 326
Shanghai, Shanghai Municipality, China, 200032
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84
Research Site 355
Shanghai, Shanghai Municipality, China, 200120
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85
Research Site 332
Xi’an, Shanxi, China, 710000
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86
Research Site 312
Chengdu, Sichuan, China, 610041
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87
Research Site 330
Chengdu, Sichuan, China, 610041
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88
Research Site 366
Chengdu, Sichuan, China, 610041
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89
Research Site 325
Chengdu, Sichuan, China, 610072
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90
Research Site 347
Tianjin, Tianjin Municipality, China, 300052
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91
Research Site 318
Tianjin, Tianjin Municipality, China, 300060
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92
Research site 368
Tianjin, Tianjin Municipality, China, 300300
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93
Research Site 324
Hangzhou, Zhejiang, China, 310014
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94
Research Site 329
Hangzhou, Zhejiang, China, 310016
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95
Research Site 331
Hangzhou, Zhejiang, China, 310022
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96
Research Site 359
Hangzhou, Zhejiang, China, 310022
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97
Research site 369
Hangzhou, Zhejiang, China, 310022
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98
Research Site 303
Taizhou, Zhejiang, China, 317099
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99
Research Site 408
Kaohsiung City, Taiwan, 807377
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100
Research Site 405
Kaohsiung City, Taiwan, 824005
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101
Research Site 406
New Taipei City, Taiwan, 235041
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102
Research Site 401
Taipei, Taiwan, 100225
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103
Research Site 402
Taipei, Taiwan, 100225
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104
Research Site 409
Taipei, Taiwan, 104217
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105
Research Site 403
Taipei, Taiwan, 110301
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106
Research Site 407
Taipei, Taiwan, 112201
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107
Research Site 404
Taoyuan, Taiwan, 333423
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Research Team
L
Ling Li
T
Tiana Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
23
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