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Dose Expansion 1 for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by DualityBio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent.
2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.
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

Summary

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

Eligible Conditions
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study treatment administration until the initiation of phase1b/2a, approximately up to 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study treatment administration until the initiation of phase1b/2a, approximately up to 12 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Phase 1/2a: ADA incidence
Phase 1/2a: ADA prevalence
Phase 1/2a: AUC0-last
+8 more

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

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Who is running the clinical trial?

DualityBio Inc.Lead Sponsor
8 Previous Clinical Trials
2,917 Total Patients Enrolled
Lily HuStudy DirectorDualityBio Inc.
~240 spots leftby Feb 2027
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