First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

May 8, 2026 updated by: DualityBio Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1123

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 400030
        • Site 230
      • Shanghai, China, 200123
        • Site 244
    • Anhui
      • Bengbu, Anhui, China, 233099
        • Site 211
      • Hefei, Anhui, China, 230031
        • Site 217
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Site 213
      • Fuzhou, Fujian, China, 350014
        • Site 214
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Site 226
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Site 245
      • Guangzhou, Guangdong, China, 510080
        • Site 219
      • Guangzhou, Guangdong, China, 510080
        • Site 234
      • Guangzhou, Guangdong, China, 510120
        • Site 225
    • Guangxi
      • Guigang, Guangxi, China, 537100
        • Site 221
      • Nanning, Guangxi, China, 530021
        • Site 235
      • Nanning, Guangxi, China, 531200
        • Site 209
    • Hainan
      • Haikou, Hainan, China, 570102
        • Site 227
    • Hebei
      • Baoding, Hebei, China, 071030
        • Site 208
      • Chengde, Hebei, China, 067000
        • Site 243
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Site 223
    • Henan
      • Anyang, Henan, China, 455000
        • Site 239
      • Zhengzhou, Henan, China, 450000
        • Site 202
    • Hubei
      • Wuhan, Hubei, China, 430021
        • Site 205
      • Wuhan, Hubei, China, 430079
        • Site 253
    • Hunan
      • Changsha, Hunan, China, 410011
        • Site 231
      • Changsha, Hunan, China, 410013
        • Site 224
      • Changsha, Hunan, China, 410013
        • Site 252
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Site 233
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Site 215
      • Ganzhou, Jiangxi, China, 341001
        • Site 246
      • Nanchang, Jiangxi, China, 330029
        • Site 242
      • Nanchang, Jiangxi, China, 330029
        • Site 250
      • Nanchang, Jiangxi, China, 330038
        • Site 229
    • Jilin
      • Changchun, Jilin, China, 130012
        • Site 201
      • Changchun, Jilin, China, 130021
        • Site 249
      • Yanbian, Jilin, China, 133000
        • Site 248
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Site 210
    • Shaanxi
      • Xi'an, Shaanxi, China, 710100
        • Site 241
    • Shandong
      • Jinan, Shandong, China, 250117
        • Site 216
      • Jining, Shandong, China, 272007
        • Site 237
      • Linyi, Shandong, China, 276034
        • Site 247
      • Linyi, Shandong, China, 276304
        • Site 212
      • Qingdao, Shandong, China, 266035
        • Site 236
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201315
        • Site 207
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Site 238
    • Sichuan
      • Chengdu, Sichuan, China, 611135
        • Site 206
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Site 203
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Site 232
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Site 240
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Site 222
      • Taizhou, Zhejiang, China, 317004
        • Site 220
      • Wenzhou, Zhejiang, China, 325015
        • Site 228
  • Puerto Rico
    • Puerto Rico
      • Mayagüez, Puerto Rico, Puerto Rico, 00682
        • Site 113
  • United States
    • Arizona
      • Bullhead City, Arizona, United States, 86442
        • Site 139
    • California
      • Cerritos, California, United States, 90703
        • Site 103
      • La Jolla, California, United States, 92093
        • Site 136
      • Los Angeles, California, United States, 90027
        • Site 127
      • Los Angeles, California, United States, 90067
        • Site 133
      • Los Angeles, California, United States, 90404
        • Site 108
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Site 131
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Site 122
      • Hialeah, Florida, United States, 33013
        • Site 142
      • Margate, Florida, United States, 33063
        • Site 114
      • Miami, Florida, United States, 33133
        • Site 120
      • Ocala, Florida, United States, 34474
        • Site 126
      • Orange City, Florida, United States, 32763
        • Site 140
      • Plantation, Florida, United States, 33322
        • Site 109
      • St. Petersburg, Florida, United States, 33709
        • Site 141
      • Tamarac, Florida, United States, 33321
        • Site 117
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Site 111
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Site 134
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Site 124
      • Detroit, Michigan, United States, 48201
        • Site 106
      • Royal Oak, Michigan, United States, 48073
        • Site 125
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Site 129
    • New York
      • Mineola, New York, United States, 11501
        • Site 160
      • New York, New York, United States, 10016
        • Site 116
      • New York, New York, United States, 10065
        • Site 102
      • Westbury, New York, United States, 11590
        • Site 130
    • North Carolina
      • Wilson, North Carolina, United States, 27895
        • Site 121
    • Ohio
      • Canton, Ohio, United States, 44718
        • Site 101
      • Cincinnati, Ohio, United States, 45219
        • Site 132
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Site 118
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Site 123
      • Pittsburgh, Pennsylvania, United States, 15224
        • Site 112
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Site 105
    • Texas
      • Arlington, Texas, United States, 76017
        • Site 110
      • Houston, Texas, United States, 77030
        • Site 104
      • Houston, Texas, United States, 77074
        • Site 115
      • Tyler, Texas, United States, 75701
        • Site 119
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Site 107
      • Falls Church, Virginia, United States, 19107
        • Site 135
    • Washington
      • Tacoma, Washington, United States, 98405
        • Site 128
      • Tacoma, Washington, United States, 98405
        • Site 138
    • Wisconsin
      • Sheboygan, Wisconsin, United States, 53081
        • Site 137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DB-1305/BNT325 Dose Level 1
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 2
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 3
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 4
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 5
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 6
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 7
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Expansion 4
Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Expansion 7
Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Expansion 8
Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Expansion 9
Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: Experimental: DB-1305/BNT325 Dose Expansion 10
Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 in combination with pembrolizumab
Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab
Combination product: Pembrolizumab
Administered I.V.
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: Experimental: DB-1305/BNT325 Dose Level 8
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: Experimental: DB-1305/BNT325 in combination with BNT327
Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.
Experimental: 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
Combination product: Pembrolizumab
Administered I.V.
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.
Experimental: 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)
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: DB-1305/BNT325 Dose Level 9
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Experimental: 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
Drug: DB-1305/BNT325
Administered Injection of Vein (I.V.)
Other Names:
  • DB-1305/BNT325 for Injection
Drug: BNT327
Administered I.V.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
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
From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months.
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
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.
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)
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.
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)
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
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
up to 28 days after Cycle 1 Day 1
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
At the end of Cycle 1 (each cycle is up to 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: 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
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 (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
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: disease-control rate (DCR)
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: 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
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 (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
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: overall survival (OS)
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 the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325
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: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325
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: peak observed concentration [Cmax] of DB-1305/BNT325
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: time to Cmax [Tmax] of DB-1305/BNT325
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: Pharmacokinetic parameters: trough concentration [Ctrough] of DB-1305/BNT325
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)
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.
within 8 cycles (each cycle is up to 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DualityBio Inc.

Collaborators

BioNTech SE

Investigators

  • Study Director: Lily Hu, DualityBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2022

Primary Completion (Estimated)

August 13, 2027

Study Completion (Estimated)

September 10, 2027

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB-1305-O-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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