Advanced Solid TumorPhase 1/2NCT05438329
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing DB-1305/BNT325, Pembrolizumab and BNT327 in people with Advanced Solid Tumor, run by DualityBio Inc. at 93 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- DB-1305/BNT325, Pembrolizumab and BNT327
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,123 participants
- Where
- 93 sitesin 3 countries
- Study dates
- 19 Jul 2022to 10 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
93 sites in 3 countries.
93 sites in 3 countries
China50 sites
Site 239
Anyang, Henan, 455000
Site 208
Baoding, Hebei, 071030
Site 211
Bengbu, Anhui, 233099
Site 201
Changchun, Jilin, 130012
Site 249
Changchun, Jilin, 130021
Site 231
Changsha, Hunan, 410011
Site 224
Changsha, Hunan, 410013
Site 252
Changsha, Hunan, 410013
Site 243
Chengde, Hebei, 067000
Site 206
Chengdu, Sichuan, 611135
Site 230
Chongqing, 400030
Site 245
Dongguan, Guangdong, 523059
Site 213
Fuzhou, Fujian, 350001
Site 214
Fuzhou, Fujian, 350014
Site 215
Ganzhou, Jiangxi, 341000
Site 246
Ganzhou, Jiangxi, 341001
Site 219
Guangzhou, Guangdong, 510080
Site 234
Guangzhou, Guangdong, 510080
Site 225
Guangzhou, Guangdong, 510120
Site 221
Guigang, Guangxi, 537100
Site 227
Haikou, Hainan, 570102
Site 222
Hangzhou, Zhejiang, 310022
Site 223
Harbin, Heilongjiang, 150081
Site 217
Hefei, Anhui, 230031
Site 216
Jinan, Shandong, 250117
Site 237
Jining, Shandong, 272007
Site 240
Kunming, Yunnan, 650118
Site 226
Lanzhou, Gansu, 730050
Site 247
Linyi, Shandong, 276034
Site 212
Linyi, Shandong, 276304
Site 242
Nanchang, Jiangxi, 330029
Site 250
Nanchang, Jiangxi, 330029
Site 229
Nanchang, Jiangxi, 330038
Site 233
Nanjing, Jiangsu, 210009
Site 235
Nanning, Guangxi, 530021
Site 209
Nanning, Guangxi, 531200
Site 236
Qingdao, Shandong, 266035
Site 207
Shanghai, Shanghai Municipality, 201315
Site 244
Shanghai, 200123
Site 210
Shenyang, Liaoning, 110042
Site 238
Taiyuan, Shanxi, 030001
Site 220
Taizhou, Zhejiang, 317004
Site 203
Tianjin, Tianjin Municipality, 300060
Site 232
Ürümqi, Xinjiang, 830000
Site 228
Wenzhou, Zhejiang, 325015
Site 205
Wuhan, Hubei, 430021
Site 253
Wuhan, Hubei, 430079
Site 241
Xi'an, Shaanxi, 710100
Site 248
Yanbian, Jilin, 133000
Site 202
Zhengzhou, Henan, 450000
United States42 sites
Site 110
Arlington, Texas, 76017
Site 139
Bullhead City, Arizona, 86442
Site 101
Canton, Ohio, 44718
Site 103
Cerritos, California, 90703
Site 134
Chicago, Illinois, 60611
Site 132
Cincinnati, Ohio, 45219
Site 122
Coral Springs, Florida, 33065
Site 124
Dearborn, Michigan, 48126
Site 106
Detroit, Michigan, 48201
Site 107
Fairfax, Virginia, 22031
Site 135
Falls Church, Virginia, 19107
Site 142
Hialeah, Florida, 33013
Site 111
Honolulu, Hawaii, 96813
Site 104
Houston, Texas, 77030
Site 115
Houston, Texas, 77074
Site 136
La Jolla, California, 92093
Site 129
Las Vegas, Nevada, 89106
Site 127
Los Angeles, California, 90027
Site 133
Los Angeles, California, 90067
Site 108
Los Angeles, California, 90404
Site 114
Margate, Florida, 33063
Site 120
Miami, Florida, 33133
Site 160
Mineola, New York, 11501
Site 105
Nashville, Tennessee, 37203
Site 116
New York, New York, 10016
Site 102
New York, New York, 10065
Site 126
Ocala, Florida, 34474
Site 118
Oklahoma City, Oklahoma, 73104
Site 140
Orange City, Florida, 32763
Site 123
Philadelphia, Pennsylvania, 19107
Site 112
Pittsburgh, Pennsylvania, 15224
Site 109
Plantation, Florida, 33322
Site 125
Royal Oak, Michigan, 48073
Site 137
Sheboygan, Wisconsin, 53081
Site 141
St. Petersburg, Florida, 33709
Site 128
Tacoma, Washington, 98405
Site 138
Tacoma, Washington, 98405
Site 117
Tamarac, Florida, 33321
Site 119
Tyler, Texas, 75701
Site 131
Washington D.C., District of Columbia, 20007
Site 130
Westbury, New York, 11590
Site 121
Wilson, North Carolina, 27895
About this study
Official title: 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
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.
Read the detailed description
This is a multicenter, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- DB-1305/BNT325, Pembrolizumab, BNT327
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1305/BNT325Drug
Also called DB-1305/BNT325 for Injection
Administered Injection of Vein (I.V.)
PembrolizumabCombination product
Administered I.V.
BNT327Drug
Administered I.V.
| Study group | Role | What they receive |
|---|---|---|
| DB-1305/BNT325 Dose Level 1 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 2 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 3 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 4 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 5 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 6 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 7 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 in combination with pembrolizumab | Experimental | Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab Receives: Drug: DB-1305/BNT325; Combination Product: Pembrolizumab |
| DB-1305/BNT325 Dose Expansion 1 | Experimental | 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 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 2 | Experimental | Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 3 | Experimental | Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 4 | Experimental | Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 5 | Experimental | 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) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 6 | Experimental | Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 7 | Experimental | Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 8 | Experimental | Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 9 | Experimental | Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| Experimental: DB-1305/BNT325 Dose Expansion 10 | Experimental | Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion 11 | Experimental | Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion PB1 | Experimental | Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab Receives: Drug: DB-1305/BNT325; Combination Product: Pembrolizumab |
| Experimental: DB-1305/BNT325 Dose Level 8 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8 Receives: Drug: DB-1305/BNT325 |
| Experimental: DB-1305/BNT325 in combination with BNT327 | Experimental | Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM1 | Experimental | Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM2 | Experimental | Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM3 | Experimental | Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM4 | Experimental | Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM5 | Experimental | Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
| DB-1305/BNT325 Dose Expansion 12 | Experimental | Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D) Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Level 9 | Experimental | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9 Receives: Drug: DB-1305/BNT325 |
| DB-1305/BNT325 Dose Expansion PM6 | Experimental | Enrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 Receives: Drug: DB-1305/BNT325; Drug: BNT327 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Measured: 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
Phase 1 \& Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
Measured: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
Phase 1 \& Phase 2a: disease-control rate (DCR)
Measured: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: time to response (TTR)
Phase 1 \& Phase 2a: time to response (TTR)
Measured: 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
Phase 1 \& Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
Measured: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: overall survival (OS)
Phase 1 \& Phase 2a: overall survival (OS)
Measured: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: (the area under the concentration-time curve from the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325
Phase 1 \& Phase 2a: Pharmacokinetic parameters: (the area under the concentration-time curve from the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325
Measured: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325
Phase 1 \& Phase 2a: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325
Measured: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: peak observed concentration [Cmax] of DB-1305/BNT325
Phase 1 \& Phase 2a: peak observed concentration [Cmax] of DB-1305/BNT325
Measured: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: time to Cmax [Tmax] of DB-1305/BNT325
Phase 1 \& Phase 2a: Pharmacokinetic parameters: time to Cmax [Tmax] of DB-1305/BNT325
Measured: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: trough concentration [Ctrough] of DB-1305/BNT325
Phase 1 \& Phase 2a: Pharmacokinetic parameters: trough concentration [Ctrough] of DB-1305/BNT325
Measured: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: anti-drug antibody (ADA) prevalence: the proportion of subjects who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of subjects having treatment-emergent ADA.
Phase 1 \& Phase 2a: anti-drug antibody (ADA) prevalence of DB-1305: the proportion of subjects who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence of DB-1305: the proportion of subjects having treatment-emergent ADA.
Measured: within 8 cycles (each cycle is up to 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start19 Jul 2022
- Primary completion13 Aug 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Lily Hu, Study director, DualityBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438329
- Sponsor's protocol ID
- DB-1305-O-1001
- Status last verified
- May 2026
- First submitted
- 14 Jun 2022
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05438329
- Acronym / sponsor ID
- DB-1305-O-1001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,123 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 13 Aug 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 30
| Arm | Type | Receives |
|---|---|---|
| DB-1305/BNT325 Dose Level 1 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1 |
| DB-1305/BNT325 Dose Level 2 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2 |
| DB-1305/BNT325 Dose Level 3 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3 |
| DB-1305/BNT325 Dose Level 4 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4 |
| DB-1305/BNT325 Dose Level 5 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5 |
| DB-1305/BNT325 Dose Level 6 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6 |
| DB-1305/BNT325 Dose Level 7 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7 |
| DB-1305/BNT325 in combination with pembrolizumab | Experimental | Drug: DB-1305/BNT325, Combination Product: PembrolizumabEnrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab |
| DB-1305/BNT325 Dose Expansion 1 | Experimental | Drug: DB-1305/BNT325subjects 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 | Experimental | Drug: DB-1305/BNT325Enrolled 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 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2 |
| DB-1305/BNT325 Dose Expansion 4 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 5 | Experimental | Drug: DB-1305/BNT325Enrolled 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 | Experimental | Drug: DB-1305/BNT325Enrolled 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 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 8 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 9 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| Experimental: DB-1305/BNT325 Dose Expansion 10 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 11 | Experimental | Drug: DB-1305/BNT325Enrolled 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 | Experimental | Drug: DB-1305/BNT325, Combination Product: PembrolizumabEnrolled 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 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8 |
| Experimental: DB-1305/BNT325 in combination with BNT327 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM1 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled 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 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled 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 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled 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 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled 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 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| DB-1305/BNT325 Dose Expansion 12 | Experimental | Drug: DB-1305/BNT325Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Level 9 | Experimental | Drug: DB-1305/BNT325Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9 |
| DB-1305/BNT325 Dose Expansion PM6 | Experimental | Drug: DB-1305/BNT325, Drug: BNT327Enrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-1305/BNT325Also: DB-1305/BNT325 for InjectionAdministered Injection of Vein (I.V.) | Drug | DB-1305/BNT325 Dose Expansion 1, DB-1305/BNT325 Dose Expansion 11, DB-1305/BNT325 Dose Expansion 12, DB-1305/BNT325 Dose Expansion 2, DB-1305/BNT325 Dose Expansion 3, DB-1305/BNT325 Dose Expansion 4, DB-1305/BNT325 Dose Expansion 5, DB-1305/BNT325 Dose Expansion 6, DB-1305/BNT325 Dose Expansion 7, DB-1305/BNT325 Dose Expansion 8, DB-1305/BNT325 Dose Expansion 9, DB-1305/BNT325 Dose Expansion PB1, DB-1305/BNT325 Dose Expansion PM6, DB-1305/BNT325 Dose Level 1, DB-1305/BNT325 Dose Level 2, DB-1305/BNT325 Dose Level 3, DB-1305/BNT325 Dose Level 4, DB-1305/BNT325 Dose Level 5, DB-1305/BNT325 Dose Level 6, DB-1305/BNT325 Dose Level 7, DB-1305/BNT325 Dose Level 9, DB-1305/BNT325 in combination with pembrolizumab, Experimental: DB-1305/BNT325 Dose Expansion 10, Experimental: DB-1305/BNT325 Dose Expansion PM1, Experimental: DB-1305/BNT325 Dose Expansion PM2, Experimental: DB-1305/BNT325 Dose Expansion PM3, Experimental: DB-1305/BNT325 Dose Expansion PM4, Experimental: DB-1305/BNT325 Dose Expansion PM5, Experimental: DB-1305/BNT325 Dose Level 8, Experimental: DB-1305/BNT325 in combination with BNT327 |
| PembrolizumabAdministered I.V. | Combination product | DB-1305/BNT325 Dose Expansion PB1, DB-1305/BNT325 in combination with pembrolizumab |
| BNT327Administered I.V. | Drug | DB-1305/BNT325 Dose Expansion PM6, Experimental: DB-1305/BNT325 Dose Expansion PM1, Experimental: DB-1305/BNT325 Dose Expansion PM2, Experimental: DB-1305/BNT325 Dose Expansion PM3, Experimental: DB-1305/BNT325 Dose Expansion PM4, Experimental: DB-1305/BNT325 Dose Expansion PM5, Experimental: DB-1305/BNT325 in combination with BNT327 |
Primary outcome
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.
Time frame: up to 28 days after Cycle 1 Day 1
Percentage of participants in Part 1 with DLTs
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of participants with TEAEs in Part 1 graded according to NCI CTCAE v5.0
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Maximum Tolerated Dose (MTD) of DB-1305/BNT325
Time frame: At the end of Cycle 1 (each cycle is up to 21 days)
MTD on the data collected during Part 1
Phase 1: RP2D of DB-1305/BNT325
Time frame: From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months.
RP2D of DB-1305/BNT325 based on the data collected during Part 1
Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0.
Time frame: Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of participants with TEAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0.
Time frame: Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: 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.
The percentage of subjects who had a best response rating of CR and PR
12 secondary outcomes
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Time frame: 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
Time frame: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
Time frame: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: time to response (TTR)
Time frame: 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
Time frame: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: overall survival (OS)
Time frame: with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: (the area under the concentration-time curve from the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325
Time frame: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325
Time frame: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: peak observed concentration [Cmax] of DB-1305/BNT325
Time frame: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: time to Cmax [Tmax] of DB-1305/BNT325
Time frame: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: trough concentration [Ctrough] of DB-1305/BNT325
Time frame: within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: anti-drug antibody (ADA) prevalence: the proportion of subjects who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of subjects having treatment-emergent ADA.
Time frame: within 8 cycles (each cycle is up to 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lily Hu study director
DualityBio Inc.
93 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB-1305/BNT325, Pembrolizumab and BNT327 in people with Advanced Solid Tumor, run by DualityBio Inc. at 93 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in China, United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 28 days after Cycle 1 Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.