RecruitingPhase 1Phase 2NCT05785741

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

Sponsor

DualityBio Inc.

Enrollment

1,000 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

Summary

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.

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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

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NCT05785741

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