DB-1317 for Cancer

Recruiting at 3 trial locations

Overseen By Jenny Li

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: DualityBio Inc.

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Heart failure, Myocardial infarction, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

233 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

I am an adult.

LVEF ≥ 50% within 28 days before enrollment

I am willing to provide tumor samples for testing.

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.

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?

Group I: DB-1317 Dose Level 5 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W

Group II: DB-1317 Dose Level 4 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W

Group III: DB-1317 Dose Level 3 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W

Group IV: DB-1317 Dose Level 2 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W

Group V: DB-1317 Dose Level 1 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W

Group VI: DB-1317 Dose Expansion 3 Experimental Treatment 1 Intervention

Subjects with advanced/unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Group VII: DB-1317 Dose Expansion 2 Experimental Treatment 1 Intervention

Subjects with advanced/unresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Group VIII: DB-1317 Dose Expansion 1 Experimental Treatment 1 Intervention

Subjects with advanced/unresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials

12

Recruited

5,800+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07141706

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 ...

2.

researchgate.net

researchgate.net/publication/396807194_Abstract_A132_DB-1317_a_novel_ADAM9-targeting_antibody-drug_conjugate_exhibits_potent_antitumor_activity_against_multiple_gastrointestinal_cancers

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.

3.

bioworld.com

bioworld.com/articles/725758-adam9-targeting-db-1317-exhibits-efficacy-against-several-solid-tumors

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 ...

4.

en.dualitybiologics.com

en.dualitybiologics.com/upload/listedco/listconews/sehk/2025/0826/2025082600874.pdf

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 ...

5.

oncologypipeline.com

oncologypipeline.com/apexonco/dualitybio-tries-float-again

DualityBio tries to float again | ApexOnco

Duality has various other projects against undisclosed targets, including the monospecific DB-1317, and the bispecific DB-1421. Around 15 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12572402/

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].

7.

cell.com

cell.com/cell-reports-medicine/fulltext/S2666-3791(25)00480-X

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, ...

8.

gastrojournal.org

gastrojournal.org/article/S0016-5085(13)00299-0/pdf

Therapeutic Advances in Pancreatic Cancer

We 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.