A Study of DB-1310 in 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-1310 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-1310 in subjects with advanced solid tumors.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new drug called DB-1310 in people with advanced or metastatic solid tumors (cancers that have spread and cannot be removed by surgery). Researchers want to understand how safe and effective it is, especially in people whose cancer has continued to grow despite previous treatments.
**You may be eligible if...**
- You are 18 or older with advanced or metastatic solid tumor cancer
- Your cancer has progressed or returned after standard treatments
- You have at least one measurable tumor visible on scans
- Your heart is pumping normally (LVEF ≥ 50%)
- You are in reasonably good overall health (able to care for yourself)
- You are willing to provide a tumor tissue sample
**You may NOT be eligible if...**
- You have previously been treated with a HER3-targeted therapy
- You have a history of significant heart failure or serious heart rhythm problems
- You have had a heart attack or unstable chest pain within the last 6 months
- You have active, uncontrolled lung disease or a history of serious lung inflammation
- You have active, untreated brain metastases with symptoms
- You are pregnant or breastfeeding
- You have active HIV or hepatitis B/C
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGDB-1310
Administered I.V.
DRUGTrastuzumab
Administered I.V.
DRUGOsimertinib
Oral
DRUGcapecitabine
Oral
Locations(24)
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Research Site 117
Coral Gables, Florida, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
BRCR global
Plantation, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
BRCR Medical Center Inc.
Tamarac, Florida, United States
Research Site 111
Atlanta, Georgia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Research site 119
Florham Park, New Jersey, United States
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
NEXT Virginia
Fairfax, Virginia, United States
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan cancer hospital
Changsha, Hunan, China
Jiangsu Province hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The first hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Research Site 222
Chengdu, Sichuan, China
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.