DB-1317 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called DB-1317 for individuals with certain types of advanced or metastatic cancers, including gastric, colorectal, and pancreatic cancers that have not responded to standard treatments. The study aims to determine the best dose and assess the safety and effectiveness of DB-1317 in these conditions. Participants will receive the treatment through an IV every three weeks. This trial may suit individuals whose advanced cancers have worsened after other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that DB-1317 is likely to be safe for humans?
Research has shown that DB-1317, a new treatment for certain solid tumors, has been tested in early lab studies. These studies evaluated its effectiveness against tumors and its safety profile. Although detailed safety information from human trials is not yet available, these early studies mark an important first step. They help scientists understand how DB-1317 might function in humans and what side effects might occur.
Since this study is in its early phase, it primarily focuses on determining the right dose and identifying any side effects. The treatment undergoes close monitoring to ensure safety for participants. Prospective trial participants should know that this phase aims to ensure the treatment's safety and establish the optimal dose.
DB-1317 is not yet approved for use outside of trials, so all safety information comes from these controlled settings. Trial participants will be closely monitored for any side effects, aiding researchers in gathering crucial safety data.12345Why do researchers think this study treatment might be promising?
Researchers are excited about DB-1317 because it offers a novel approach for treating cancers like gastric, colorectal, and pancreatic ductal adenocarcinoma, especially in patients who haven't responded to standard treatments. Most current treatments, such as chemotherapy and targeted therapies, work by attacking rapidly dividing cells or specific cancer cell proteins. Unlike these, DB-1317 may target cancer cells through a unique mechanism that could potentially improve effectiveness and reduce side effects. Additionally, DB-1317 is administered via intravenous infusion every three weeks, which might offer a more convenient and manageable regimen for patients compared to some existing options.
What evidence suggests that DB-1317 might be an effective treatment for cancer?
Research has shown that DB-1317, a new treatment under investigation in this trial, has produced promising results in lab studies for several types of cancer. It targets a protein called ADAM9, often found in higher amounts in certain cancer cells. In these studies, DB-1317 effectively reduced tumor growth in models of stomach, pancreatic, and colon cancer. Early data also suggest it is safe for patients who have not responded to standard treatments. This trial will explore various dose levels and expansions of DB-1317, offering hope as a potential new option for treating advanced cancers.12678
Who Is on the Research Team?
Lily Hu
Principal Investigator
DualityBio Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with advanced or metastatic solid tumors. Participants must meet specific health criteria not detailed here. People who don't fit the study's requirements, possibly due to other medical conditions or treatments that could interfere with the trial, can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a: Dose Escalation
Participants receive increasing dose levels of DB-1317 every 3 weeks to identify the MTD or MAD
Phase 1b: Dose Expansion
Randomized expansion cohorts to evaluate safety, tolerability, and preliminary efficacy of DB-1317
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DB-1317
Find a Clinic Near You
Who Is Running the Clinical Trial?
DualityBio Inc.
Lead Sponsor