233 Participants Needed

DB-1317 for Cancer

Recruiting at 2 trial locations
JG
XW
JL
Overseen ByJenny Li
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

LH

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

I am an adult.
LVEF ≥ 50% within 28 days before enrollment
I am willing to provide tumor samples for testing.
See 5 more

Exclusion Criteria

I have previously been treated with ADAM9 targeted therapy.
I have had lung inflammation not caused by an infection.
I have a serious eye condition affecting my cornea.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive increasing dose levels of DB-1317 every 3 weeks to identify the MTD or MAD

Up to 12 months
Every 3 weeks

Phase 1b: Dose Expansion

Randomized expansion cohorts to evaluate safety, tolerability, and preliminary efficacy of DB-1317

Up to 12 months
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 1 year post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • DB-1317
Trial Overview The study tests multiple doses of a new drug called DB-1317 in two phases: Phase 1a to find the maximum tolerated dose and Phase 1b to assess safety and early signs of effectiveness at different doses in selected tumor types.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: DB-1317 Dose Level 5Experimental Treatment1 Intervention
Group II: DB-1317 Dose Level 4Experimental Treatment1 Intervention
Group III: DB-1317 Dose Level 3Experimental Treatment1 Intervention
Group IV: DB-1317 Dose Level 2Experimental Treatment1 Intervention
Group V: DB-1317 Dose Level 1Experimental Treatment1 Intervention
Group VI: DB-1317 Dose Expansion 3Experimental Treatment1 Intervention
Group VII: DB-1317 Dose Expansion 2Experimental Treatment1 Intervention
Group VIII: DB-1317 Dose Expansion 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials
12
Recruited
5,800+

Citations

A Study of DB-1317 in Selected Advanced/Metastatic Solid ...This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the ...
DB-1317, a novel ADAM9-targeting antibody-drug ...In vivo, DB-1317 showed strong anti-tumor activity in gastric (NUGC-4, NUGC-3, SNU-5, Hs746T) and pancreatic (HPAFII, Panc08.13) cancer models.
ADAM9-targeting DB-1317 exhibits efficacy against several ...In vivo, DB-1317 showed potent antitumor activity in gastric, pancreatic and colorectal cancer models, with tumor growth inhibition being higher ...
Duality Biotherapeutics, Inc. 映恩生物The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard ...
DualityBio tries to float again | ApexOncoDuality has various other projects against undisclosed targets, including the monospecific DB-1317, and the bispecific DB-1421. Around 15 ...
Identifying health conditions associated with an increased risk ...Pancreatic ductal adenocarcinoma (PDAC) ranks among the deadliest cancers mainly due to its late diagnosis and chemoresistance [1].
CD40 agonist mitazalimab with mFOLFIRINOX in untreated ...These results suggest encouraging efficacy and a manageable safety profile of mitazalimab in combination with mFOLFIRINOX in the treatment of mPDAC; however, ...
Therapeutic Advances in Pancreatic CancerWe review the major advances in pancreatic cancer therapy during the last 5 years, and discuss how these have set the stage for greater progress in the near.
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