First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
NCT ID: NCT05438329
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
1123 participants
INTERVENTIONAL
2022-07-19
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DB-1305/BNT325 Dose Level 1
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 2
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 3
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 4
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 5
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 6
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 7
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 in combination with pembrolizumab
Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab
DB-1305/BNT325
Administered Injection of Vein (I.V.)
Pembrolizumab
Administered I.V.
DB-1305/BNT325 Dose Expansion 1
subjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 2
Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 3
Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 4
Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 5
Enrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 6
Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 7
Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 8
Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 9
Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
Experimental: DB-1305/BNT325 Dose Expansion 10
Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 11
Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion PB1
Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab
DB-1305/BNT325
Administered Injection of Vein (I.V.)
Pembrolizumab
Administered I.V.
Experimental: DB-1305/BNT325 Dose Level 8
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8
DB-1305/BNT325
Administered Injection of Vein (I.V.)
Experimental: DB-1305/BNT325 in combination with BNT327
Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
Experimental: DB-1305/BNT325 Dose Expansion PM1
Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
Experimental: DB-1305/BNT325 Dose Expansion PM2
Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
Experimental: DB-1305/BNT325 Dose Expansion PM3
Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
Experimental: DB-1305/BNT325 Dose Expansion PM4
Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
Experimental: DB-1305/BNT325 Dose Expansion PM5
Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
DB-1305/BNT325 Dose Expansion 12
Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Level 9
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9
DB-1305/BNT325
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion PM6
Enrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325
Administered Injection of Vein (I.V.)
BNT327
Administered I.V.
Interventions
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DB-1305/BNT325
Administered Injection of Vein (I.V.)
Pembrolizumab
Administered I.V.
BNT327
Administered I.V.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progressed on or after standard systemic treatments or for which no standard treatment is available.
* At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria.
* Has a life expectancy of ≥ 3 months.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
* Has Left Ventricular Ejection Fraction (LVEF) ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
* Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.
* Has adequate treatment washout period prior to Day 1 of Cycle 1.
* Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of Trop-2 level and other biomarkers if not contraindicated.
* Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
Exclusion Criteria
* Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
* Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
* Has a medical history of non-infectious Interstitial Lung Diseases (ILD)/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Has a lung-specific intercurrent clinically significant illness.
* Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
* Subjects have human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness are not eligible for enrollment; However, subjects have had HIV infection with a cluster of differentiation 4 (CD4)+ T cell count \> 350 cells/µL and no history of an AIDS-defining illness are eligible for entry.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
DualityBio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lily Hu
Role: STUDY_DIRECTOR
DualityBio Inc.
Locations
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Site 103
Cerritos, California, United States
Site 108
Los Angeles, California, United States
D&H Cancer Research Center Llc
Margate, Florida, United States
Site 109
Plantation, Florida, United States
BRCR Medical Center Inc.
Tamarac, Florida, United States
Site 106
Detroit, Michigan, United States
Site 102
New York, New York, United States
Site 101
Canton, Ohio, United States
Site 105
Nashville, Tennessee, United States
Site 110
Arlington, Texas, United States
Site 104
Houston, Texas, United States
Site 107
Fairfax, Virginia, United States
Site 211
Bengbu, Anhui, China
Site 217
Hefei, Anhui, China
Site 213
Fuzhou, Fujian, China
Site 209
Nanning, Guangxi, China
Site 221
Guigang, Guanxi, China
Site 202
Zhengzhou, Henan, China
Site 205
Wuhan, Hubei, China
Site 208
Ganzhou, Jiangxi, China
Site 201
Changchun, Jilin, China
Site 210
Shenyang, Liaoning, China
Site 216
Jinan, Shandong, China
Site 212
Linyi, Shandong, China
Site 207
Shanghai, Shanghai Municipality, China
Site 206
Chengdu, Sichuan, China
Site 203
Tianjin, Tianjin Municipality, China
Site 220
Taizhou, Zhejiang, China
Site 219
Guangzhou, , China
BRCR GLOBAL Puerto Rico LLC.
Mayagüez, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Omkar Marathe, MD
Role: primary
Aaron E. Lisberg, MD
Role: primary
DAVID KAHN, MD
Role: primary
Harshad Amin, MD
Role: primary
Chintan Gandhi, MD
Role: primary
Hirva Mamdani, MD
Role: primary
Maria Michelle Rubinstein, MD
Role: primary
Nashat Y. Gabrail, MD
Role: primary
Erika Paige Hamilton, MD
Role: primary
Gerald Edelman, MD, PhD
Role: primary
Senthil Damodaran, MD
Role: primary
Alexander Spira, MD
Role: primary
Dianming Li, MD
Role: primary
Zhihong Zhang, PhD
Role: primary
Xiangqi Chen, PhD
Role: primary
Weimin Xie, PhD
Role: primary
Yan Wei
Role: primary
Min Yan, PhD
Role: primary
Xiaorong Dong, MD
Role: primary
Hua Yang, MD
Role: primary
Ying Cheng, MD
Role: primary
Tao Sun, Doctor
Role: primary
Yuping Sun, PhD
Role: primary
Jianhua Shi, MD
Role: primary
Jian Zhang, Doctor
Role: primary
Lu Li, MD
Role: primary
Chen Wang, MD
Role: primary
Dongqing Lv, MD
Role: primary
Haiyan Tu
Role: primary
Maryangely Moreno Campa, MD
Role: primary
Other Identifiers
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DB-1305-O-1001
Identifier Type: -
Identifier Source: org_study_id
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