Actively Recruiting
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2026-03-27
360
Participants Needed
36
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
CONDITIONS
Official Title
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 18 years at the time of voluntarily signing informed consent.
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.
- At least one measurable lesion assessed by the Investigator according to RECIST v1.1 criteria (applicable to backfill participants in phase 1a and participants in phase 1b/2a).
- Life expectancy of 60 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Left ventricular ejection fraction (LVEF) 60 50% by echocardiography or multiple-gated acquisition (MUGA) within 28 days before enrollment.
- Adequate organ function within 7 days prior to first dose.
- Adequate treatment washout period prior to first dose.
- Willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy if feasible.
- Capable of understanding study procedures and risks, able to provide written consent, and comply with study requirements.
- Male and female participants of reproductive potential must agree to avoid pregnancy during the study and for specified months after last dose.
- Male participants must not freeze or donate sperm during the study and for at least 4 months after last dose; female participants must not donate or retrieve ova during the study and for at least 7 months after last dose.
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy or ADC containing a topoisomerase I inhibitor payload.
- History of symptomatic congestive heart failure (NYHA classes II-IV) or serious cardiac arrhythmia requiring treatment.
- History of myocardial infarction or unstable angina within 6 months before enrollment.
- QTcF prolongation > 470 ms based on 12-lead ECG in triplicate.
- History or current interstitial lung diseases or suspected by imaging at screening.
- Underlying pulmonary disorders including recent pulmonary emboli, severe asthma, severe COPD, restrictive lung disease, or need for supplemental oxygen.
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapies allowed).
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before first dose.
- Known HIV infection.
- Active viral hepatitis.
- Lactating or pregnant women.
- Spinal cord compression or clinically active symptomatic CNS metastases requiring corticosteroids or anticonvulsants (stable asymptomatic CNS metastases allowed).
- Unresolved toxicities from previous anticancer therapy above Grade 1 or baseline.
- Prior immune-related adverse event causing permanent immune checkpoint inhibitor discontinuation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Site USA12-0
Los Angeles, California, United States, 90095
Actively Recruiting
2
Site USA08-0
Newport Beach, California, United States, 92663
Actively Recruiting
3
Site USA06-0
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
Site USA02-0
Florida City, Florida, United States, 32827
Actively Recruiting
5
Site USA11-0
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Site USA03
Huntersville, North Carolina, United States, 28078
Actively Recruiting
7
Site USA05-0
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
8
Site USA07-0
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
Site USA09-0
West Valley City, Utah, United States, 84119
Actively Recruiting
10
AUS03-0
North Ryde, New South Wales, Australia, 2109
Actively Recruiting
11
AUS01-0
Randwick, New South Wales, Australia, 2031
Actively Recruiting
12
AUS02-0
Nedlands, Washington, Australia, 6009
Actively Recruiting
13
Site CHN24-0
Hefei, Anhui, China, 230000
Not Yet Recruiting
14
Site CHN39-0
Hefei, Anhui, China, 230031
Not Yet Recruiting
15
Site CHN28-0
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
16
Site CHN13-0
Jilin, Changchun, China, 130000
Not Yet Recruiting
17
Site CHN16-0
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
18
Site CHN20-0
Fuzhou, Fujian, China, 350000
Actively Recruiting
19
Site CHN32-0
Nanning, Guangxi, China, 530012
Not Yet Recruiting
20
Site CHN08-0
Harbin, Heilongjiang, China, 150001
Actively Recruiting
21
Site CHN23-0
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
22
Site CHN03-0
Luoyang, Henan, China, 471000
Actively Recruiting
23
Site CHN09-0
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
24
Site CHN25-0
Zhengzhou, Henan, China, 451191
Not Yet Recruiting
25
Site CHN34-0
Wuhan, Hubei, China, 430079
Actively Recruiting
26
Site CHN21-0
Changsha, Hunan, China, 410011
Actively Recruiting
27
Site CHN31-0
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
28
Site CHN29-0
Jinan, Shandong, China, 250117
Not Yet Recruiting
29
Site CHN26-0
Linyi, Shandong, China, 276034
Actively Recruiting
30
Site CHN01-0
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
31
Site CHN15-0
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
32
Site CHN18-0
Chengdu, Sichuan, China, 610041
Actively Recruiting
33
Site CHN38-0
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
34
Site CHN19-0
Kunming, Yunnan, China, 650118
Not Yet Recruiting
35
Site CHN17-0
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
36
Site CHN37-0
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
Research Team
M
Milly Zang
CONTACT
C
Cathy Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
17
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