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DB-1419 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by DualityBio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment
Must not have
Prior treatment with B7-H3 targeted therapy
Has a medical history of symptomatic congestive heart failure (New York Heart Association [NYHA] classes II-IV or serious cardiac arrhythmia requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first study treatment administration until the initiation of phase1b/2a, approximately up to 12 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called DB-1419 in patients with advanced or metastatic solid tumors.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic solid tumors that have worsened after standard treatments, or when no standard treatment exists. Participants must have a measurable lesion, be in good physical condition (ECOG score of 0-1), and expect to live at least three more months. They should not have had certain heart conditions, prior B7-H3 therapy, significant QTcF prolongation, active autoimmune diseases requiring recent treatment, HIV infection, symptomatic CNS metastases without stability post-treatment, severe lung diseases or infections needing IV drugs within the last two weeks.
What is being tested?
The study tests DB-1419's safety and effectiveness on various advanced/metastatic solid tumors. It's a first-in-human research divided into phases: Phase 1a/1b determines the safe dosage while Phase 2a assesses how well it works against specific tumor types.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to cancer therapies such as fatigue, nausea, inflammation in organs due to immune response from the drug (since it targets B7-H3/PD-L1 pathways), allergic reactions at infusion sites and possibly changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still care for myself.
Select...
My heart's pumping ability is normal, confirmed by a heart scan.
Select...
I understand the study's procedures and risks, can consent in writing, and will follow the study plan.
Select...
I am 18 years or older and can consent to treatment.
Select...
My cancer is advanced, cannot be surgically removed, and has not responded to or I have refused standard treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with B7-H3 targeted therapy.
Select...
I have a history of serious heart issues, including heart failure or arrhythmia.
Select...
I have or might have lung scarring or inflammation according to my medical records or recent scans.
Select...
I have a serious lung condition or need extra oxygen.
Select...
I have not needed IV treatment for an infection in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first study treatment administration until the initiation of phase1b/2a, approximately up to 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study treatment administration until the initiation of phase1b/2a, approximately up to 12 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)
Phase 1/2a: Percentage of Participants with serious AE (SAE)
Phase 1a: Maximum Tolerated Dose (MTD)
+2 moreSecondary study objectives
Phase 1/2a: ADA incidence
Phase 1/2a: ADA prevalence
Phase 1/2a: AUC0-last
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
14Treatment groups
Experimental Treatment
Group I: Dose Level 6Experimental Treatment1 Intervention
Enrolled subjects will receive DB-1419 at Dose Level 6
Group II: Dose Level 5Experimental Treatment1 Intervention
Enrolled subjects will receive DB-1419 at Dose Level 5
Group III: Dose Level 4Experimental Treatment1 Intervention
Enrolled subjects will receive DB-1419 at Dose Level 4
Group IV: Dose Level 3Experimental Treatment1 Intervention
Enrolled subjects will receive DB-1419 at Dose Level 3
Group V: Dose Level 2Experimental Treatment1 Intervention
Enrolled subjects will receive DB-1419 at Dose Level 2
Group VI: Dose Level 1Experimental Treatment1 Intervention
Enrolled subjects will receive DB-1419 at Dose Level 1
Group VII: Dose Expansion 8Experimental Treatment1 Intervention
Group VIII: Dose Expansion 7Experimental Treatment1 Intervention
Group IX: Dose Expansion 6Experimental Treatment1 Intervention
Group X: Dose Expansion 5Experimental Treatment1 Intervention
Group XI: Dose Expansion 4Experimental Treatment1 Intervention
Group XII: Dose Expansion 3Experimental Treatment1 Intervention
Group XIII: Dose Expansion 2Experimental Treatment1 Intervention
Group XIV: Dose Expansion 1Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
DualityBio Inc.Lead Sponsor
9 Previous Clinical Trials
4,562 Total Patients Enrolled
Lily HuStudy DirectorDualityBio Inc.
6 Previous Clinical Trials
3,178 Total Patients Enrolled