360 Participants Needed

DB-1419 for Advanced Cancer

Recruiting at 18 trial locations
DL
PW
Overseen ByPhyllis Wu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires an adequate treatment washout period (time without taking certain medications) before the first dose of the study treatment, so you may need to stop some of your current medications. It's best to discuss this with the trial team to understand which medications are affected.

What safety data exists for DB-1419 in humans?

BBR 2778, which may be related to DB-1419, has been studied in humans and shows no significant heart-related side effects. However, it can cause low white blood cell counts (neutropenia), nausea, vomiting, and blue discoloration of skin and urine.12345

What is the purpose of this trial?

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors

Research Team

LH

Lily Hu

Principal Investigator

DualityBio Inc.

Eligibility Criteria

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.

Inclusion Criteria

I have at least one tumor that can be measured.
Has adequate treatment washout period prior to the first dose of study treatment
Has a life expectancy of ≥ 3 months
See 6 more

Exclusion Criteria

I had a heart attack or unstable chest pain in the last 6 months.
I have previously been treated with B7-H3 targeted therapy.
Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DB-1419 at various dose levels to assess safety, tolerability, and preliminary antitumor activity

8 cycles (each cycle is 21 days or 14 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • DB-1419
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials
12
Recruited
5,800+

Findings from Research

BBR 2778, a new aza-anthracenedione, was found to have a maximum tolerated dose of 84 mg/m2 with neutropenia identified as the dose-limiting toxicity in a phase I study involving 26 patients with advanced non-Hodgkin's lymphoma.
The drug demonstrated promising antitumor activity, achieving three complete remissions and two partial remissions, indicating its potential effectiveness in patients who have not responded to previous treatments.
Phase I study of BBR 2778, a new aza-anthracenedione, in advanced or refractory non-Hodgkin's lymphoma.Borchmann, P., Schnell, R., Knippertz, R., et al.[2020]
In a phase-II study involving 33 patients with relapsed aggressive non-Hodgkin's lymphoma (NHL), BBR 2778 demonstrated significant anti-tumor activity, achieving 5 complete and 4 partial remissions, with response durations lasting up to 17+ months.
The treatment was generally well tolerated, with neutropenia being the main side effect, suggesting that BBR 2778 could be a promising option for elderly patients who have already undergone multiple treatments.
Phase-II study of the new aza-anthracenedione, BBR 2778, in patients with relapsed aggressive non-Hodgkin's lymphomas.Borchmann, P., Morschhauser, F., Parry, A., et al.[2014]
In a phase 2 trial involving 145 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), loncastuximab tesirine demonstrated a significant overall response rate of 48.3%, indicating its effectiveness as a treatment option for this challenging patient population.
The treatment was associated with an acceptable safety profile, with serious adverse events occurring in 39% of patients, but none were directly linked to loncastuximab tesirine, suggesting it may be a safe option for heavily pretreated patients.
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial.Caimi, PF., Ai, W., Alderuccio, JP., et al.[2021]

References

Phase I study of BBR 2778, a new aza-anthracenedione, in advanced or refractory non-Hodgkin's lymphoma. [2020]
Phase-II study of the new aza-anthracenedione, BBR 2778, in patients with relapsed aggressive non-Hodgkin's lymphomas. [2014]
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. [2021]
A clinical phase I and pharmacokinetic study of BBR 2778, a novel anthracenedione analogue, administered intravenously, 3 weekly. [2019]
A phase I and pharmacokinetic study of the novel aza-anthracenedione compound BBR 2778 in patients with advanced solid malignancies. [2014]
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