First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors
1 other identifier
interventional
1,123
3 countries
93
Brief Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2022
Longer than P75 for phase_1
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 10, 2027
May 12, 2026
May 1, 2026
5.1 years
June 14, 2022
May 8, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Percentage of participants in Part 1 with DLTs
up to 28 days after Cycle 1 Day 1
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAEs in Part 1 graded according to NCI CTCAE v5.0
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Maximum Tolerated Dose (MTD) of DB-1305/BNT325
MTD on the data collected during Part 1
At the end of Cycle 1 (each cycle is up to 21 days)
Phase 1: RP2D of DB-1305/BNT325
RP2D of DB-1305/BNT325 based on the data collected during Part 1
From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months.
Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0.
Percentage of participants with TEAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
The percentage of subjects who had a best response rating of CR and PR
Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.
Secondary Outcomes (12)
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: time to response (TTR)
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
- +7 more secondary outcomes
Study Arms (30)
DB-1305/BNT325 Dose Level 1
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 1
DB-1305/BNT325 Dose Level 2
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 2
DB-1305/BNT325 Dose Level 3
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 3
DB-1305/BNT325 Dose Level 4
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 4
DB-1305/BNT325 Dose Level 5
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 5
DB-1305/BNT325 Dose Level 6
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 6
DB-1305/BNT325 Dose Level 7
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 7
DB-1305/BNT325 in combination with pembrolizumab
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab
DB-1305/BNT325 Dose Expansion 1
EXPERIMENTALsubjects 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 Dose Expansion 2
EXPERIMENTALEnrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325 Dose Expansion 3
EXPERIMENTALEnrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325 Dose Expansion 4
EXPERIMENTALEnrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 5
EXPERIMENTALEnrolled 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 Dose Expansion 6
EXPERIMENTALEnrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 7
EXPERIMENTALEnrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 8
EXPERIMENTALEnrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 9
EXPERIMENTALEnrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Experimental: DB-1305/BNT325 Dose Expansion 10
EXPERIMENTALEnrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 11
EXPERIMENTALEnrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion PB1
EXPERIMENTALEnrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab
Experimental: DB-1305/BNT325 Dose Level 8
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 8
Experimental: DB-1305/BNT325 in combination with BNT327
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM1
EXPERIMENTALEnrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM2
EXPERIMENTALEnrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM3
EXPERIMENTALEnrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM4
EXPERIMENTALEnrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM5
EXPERIMENTALEnrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325 Dose Expansion 12
EXPERIMENTALEnrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Level 9
EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 9
DB-1305/BNT325 Dose Expansion PM6
EXPERIMENTALEnrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Interventions
Administered Injection of Vein (I.V.)
Administered I.V.
Administered I.V.
Eligibility Criteria
You may qualify if:
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
- 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.
You may not qualify if:
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DualityBio Inc.lead
- BioNTech SEcollaborator
Study Sites (93)
Site 139
Bullhead City, Arizona, 86442, United States
Site 103
Cerritos, California, 90703, United States
Site 136
La Jolla, California, 92093, United States
Site 127
Los Angeles, California, 90027, United States
Site 133
Los Angeles, California, 90067, United States
Site 108
Los Angeles, California, 90404, United States
Site 131
Washington D.C., District of Columbia, 20007, United States
Site 122
Coral Springs, Florida, 33065, United States
Site 142
Hialeah, Florida, 33013, United States
Site 114
Margate, Florida, 33063, United States
Site 120
Miami, Florida, 33133, United States
Site 126
Ocala, Florida, 34474, United States
Site 140
Orange City, Florida, 32763, United States
Site 109
Plantation, Florida, 33322, United States
Site 141
St. Petersburg, Florida, 33709, United States
Site 117
Tamarac, Florida, 33321, United States
Site 111
Honolulu, Hawaii, 96813, United States
Site 134
Chicago, Illinois, 60611, United States
Site 124
Dearborn, Michigan, 48126, United States
Site 106
Detroit, Michigan, 48201, United States
Site 125
Royal Oak, Michigan, 48073, United States
Site 129
Las Vegas, Nevada, 89106, United States
Site 160
Mineola, New York, 11501, United States
Site 116
New York, New York, 10016, United States
Site 102
New York, New York, 10065, United States
Site 130
Westbury, New York, 11590, United States
Site 121
Wilson, North Carolina, 27895, United States
Site 101
Canton, Ohio, 44718, United States
Site 132
Cincinnati, Ohio, 45219, United States
Site 118
Oklahoma City, Oklahoma, 73104, United States
Site 123
Philadelphia, Pennsylvania, 19107, United States
Site 112
Pittsburgh, Pennsylvania, 15224, United States
Site 105
Nashville, Tennessee, 37203, United States
Site 110
Arlington, Texas, 76017, United States
Site 104
Houston, Texas, 77030, United States
Site 115
Houston, Texas, 77074, United States
Site 119
Tyler, Texas, 75701, United States
Site 107
Fairfax, Virginia, 22031, United States
Site 135
Falls Church, Virginia, 19107, United States
Site 128
Tacoma, Washington, 98405, United States
Site 138
Tacoma, Washington, 98405, United States
Site 137
Sheboygan, Wisconsin, 53081, United States
Site 211
Bengbu, Anhui, 233099, China
Site 217
Hefei, Anhui, 230031, China
Site 213
Fuzhou, Fujian, 350001, China
Site 214
Fuzhou, Fujian, 350014, China
Site 226
Lanzhou, Gansu, 730050, China
Site 245
Dongguan, Guangdong, 523059, China
Site 219
Guangzhou, Guangdong, 510080, China
Site 234
Guangzhou, Guangdong, 510080, China
Site 225
Guangzhou, Guangdong, 510120, China
Site 221
Guigang, Guangxi, 537100, China
Site 235
Nanning, Guangxi, 530021, China
Site 209
Nanning, Guangxi, 531200, China
Site 227
Haikou, Hainan, 570102, China
Site 208
Baoding, Hebei, 071030, China
Site 243
Chengde, Hebei, 067000, China
Site 223
Harbin, Heilongjiang, 150081, China
Site 239
Anyang, Henan, 455000, China
Site 202
Zhengzhou, Henan, 450000, China
Site 205
Wuhan, Hubei, 430021, China
Site 253
Wuhan, Hubei, 430079, China
Site 231
Changsha, Hunan, 410011, China
Site 224
Changsha, Hunan, 410013, China
Site 252
Changsha, Hunan, 410013, China
Site 233
Nanjing, Jiangsu, 210009, China
Site 215
Ganzhou, Jiangxi, 341000, China
Site 246
Ganzhou, Jiangxi, 341001, China
Site 242
Nanchang, Jiangxi, 330029, China
Site 250
Nanchang, Jiangxi, 330029, China
Site 229
Nanchang, Jiangxi, 330038, China
Site 201
Changchun, Jilin, 130012, China
Site 249
Changchun, Jilin, 130021, China
Site 248
Yanbian, Jilin, 133000, China
Site 210
Shenyang, Liaoning, 110042, China
Site 241
Xi'an, Shaanxi, 710100, China
Site 216
Jinan, Shandong, 250117, China
Site 237
Jining, Shandong, 272007, China
Site 247
Linyi, Shandong, 276034, China
Site 212
Linyi, Shandong, 276304, China
Site 236
Qingdao, Shandong, 266035, China
Site 207
Shanghai, Shanghai Municipality, 201315, China
Site 238
Taiyuan, Shanxi, 030001, China
Site 206
Chengdu, Sichuan, 611135, China
Site 203
Tianjin, Tianjin Municipality, 300060, China
Site 232
Ürümqi, Xinjiang, 830000, China
Site 240
Kunming, Yunnan, 650118, China
Site 222
Hangzhou, Zhejiang, 310022, China
Site 220
Taizhou, Zhejiang, 317004, China
Site 228
Wenzhou, Zhejiang, 325015, China
Site 230
Chongqing, 400030, China
Site 244
Shanghai, 200123, China
Site 113
Mayagüez, Puerto Rico, 00682, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lily Hu
DualityBio Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 29, 2022
Study Start
July 19, 2022
Primary Completion (Estimated)
August 13, 2027
Study Completion (Estimated)
September 10, 2027
Last Updated
May 12, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share