Actively Recruiting
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2026-04-06
1000
Participants Needed
24
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
CONDITIONS
Official Title
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have relapsed or progressed after standard treatments, are intolerant to standard treatments, or have no standard treatment options
- Have at least one measurable lesion based on RECIST 1.1 criteria
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography or MUGA within 28 days before enrollment
- Willing to provide archived tumor tissue or undergo fresh biopsy for biomarker analysis if possible
- Able to understand study procedures and provide written informed consent
- Agree to use effective contraception during the study and for specified periods after last dose
- Males must agree not to freeze or donate sperm during the study and for 4 months after last dose
- Females must agree not to donate or retrieve ova during the study and for 7 months after last dose
- For Phase 1 monotherapy: have pathologically confirmed advanced/unresectable or metastatic solid tumors refractory or intolerant to standard treatment
You will not qualify if you...
- Previous treatment with HER3 targeted therapy
- Previous treatment with antibody drug conjugate containing topoisomerase I inhibitor (with some exceptions)
- History of symptomatic congestive heart failure (NYHA classes II-IV) or serious cardiac arrhythmia needing treatment
- History of myocardial infarction, unstable angina, or stroke within 6 months before first dose; uncontrolled hypertension
- Significant abnormalities in resting ECG such as complete left bundle branch block or high-degree heart block
- QTc interval prolongation over 470 milliseconds on ECG
- Unable or unwilling to stop drugs known to prolong QT interval
- For some cohorts: current use of strong CYP3A4 inducers that cannot be stopped
- History or current interstitial lung disease, pneumonitis, or radiation pneumonitis requiring steroids
- Significant lung diseases, autoimmune or inflammatory disorders with lung involvement, or prior complete lung removal
- Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals
- Known HIV infection
- Active viral hepatitis
- Pregnant or breastfeeding women
- Active symptomatic central nervous system metastases except stable treated cases
- Unresolved toxicities from prior cancer therapy above grade 1 except alopecia
- Multiple primary cancers within 5 years except certain treated non-melanoma skin cancers or in situ diseases
- Substance abuse or other medical conditions increasing risk or interfering with study
- Known hypersensitivity to study drugs or ingredients
- Other reasons making participation unsuitable per investigator judgment
- For some cohorts: refractory nausea, chronic GI disease, inability to swallow study drugs, or significant bowel resection impacting drug absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
2
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
3
Research Site 117
Coral Gables, Florida, United States, 33146
Withdrawn
4
D&H Cancer Research Center LLC
Margate, Florida, United States, 33063
Withdrawn
5
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
6
BRCR global
Plantation, Florida, United States, 33322
Actively Recruiting
7
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
8
BRCR Medical Center Inc.
Tamarac, Florida, United States, 33321
Actively Recruiting
9
Research Site 111
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
12
Research site 119
Florham Park, New Jersey, United States, 07932
Active, Not Recruiting
13
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
14
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
17
Hunan cancer hospital
Changsha, Hunan, China, 410000
Actively Recruiting
18
Jiangsu Province hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
19
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214000
Actively Recruiting
20
The first hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
21
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110010
Actively Recruiting
22
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
23
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610030
Actively Recruiting
24
Research Site 222
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
T
Tiana Zhao
CONTACT
L
Lingling Gu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
25
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